<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03011892</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 18424-206</org_study_id>
    <nct_id>NCT03011892</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis</brief_title>
  <official_title>A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream&#xD;
      once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with&#xD;
      vehicle cream BID.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">March 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 10, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8</measure>
    <time_frame>Baseline, Week 2 and 8</time_frame>
    <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8</measure>
    <time_frame>Week 2, 4 and 8</time_frame>
    <description>The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in EASI Score at Week 4</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Achieve EASI-50</measure>
    <time_frame>From Baseline to Week 8</time_frame>
    <description>Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8</measure>
    <time_frame>Week 2, 4 and 8</time_frame>
    <description>IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8</measure>
    <time_frame>Baseline, Week 2, 4 and 8</time_frame>
    <description>The Itch NRS is a once-per-24 hours (&quot;daily&quot;) participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With At Least One Adverse Event (AEs) and as Per Severity</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">307</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Double Blind (DB): Vehicle BID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DB: Ruxolitinib 0.15% Once Daily (QD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DB: Ruxolitinib 0.5% QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DB: Ruxolitinib 1.5% QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DB: Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib 0.15% Cream QD</intervention_name>
    <description>Ruxolitinib 0.15% cream QD</description>
    <arm_group_label>DB: Ruxolitinib 0.15% Once Daily (QD)</arm_group_label>
    <other_name>INCB018424</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib 0.5% Cream QD</intervention_name>
    <description>Ruxolitinib 0.5% cream QD</description>
    <arm_group_label>DB: Ruxolitinib 0.5% QD</arm_group_label>
    <other_name>INCB018424</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib 1.5% Cream QD</intervention_name>
    <description>Ruxolitinib 1.5% cream QD</description>
    <arm_group_label>DB: Ruxolitinib 1.5% QD</arm_group_label>
    <other_name>INCB018424</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib 1.5% Cream BID</intervention_name>
    <description>Ruxolitinib 1.5% cream BID</description>
    <arm_group_label>DB: Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_label>OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_label>OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_label>OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_label>OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_label>OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID</arm_group_label>
    <arm_group_label>Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID</arm_group_label>
    <other_name>INCB018424</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone 0.1% Cream BID</intervention_name>
    <description>Triamcinolone 0.1% cream BID</description>
    <arm_group_label>DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Cream BID</intervention_name>
    <description>Vehicle cream BID</description>
    <arm_group_label>DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID</arm_group_label>
    <arm_group_label>Double Blind (DB): Vehicle BID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka&#xD;
             criteria.&#xD;
&#xD;
          -  Participants with a history of AD for at least 2 years.&#xD;
&#xD;
          -  Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at&#xD;
             screening and baseline.&#xD;
&#xD;
          -  Participants with body surface area (BSA) of AD involvement, excluding the face and&#xD;
             intertriginous areas, of 3% to 20% at screening and baseline.&#xD;
&#xD;
          -  Participants who agree to discontinue all agents used to treat AD from screening&#xD;
             through the final follow-up visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with evidence of active acute or chronic infections.&#xD;
&#xD;
          -  Use of topical treatments for AD (other than bland emollients) within 2 weeks of&#xD;
             baseline.&#xD;
&#xD;
          -  Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable&#xD;
             corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine)&#xD;
             within 4 weeks or 5 half-lives of baseline (whichever is longer).&#xD;
&#xD;
          -  Participants with other dermatologic disease besides AD whose presence or treatments&#xD;
             could complicate the assessment of disease (eg, psoriasis).&#xD;
&#xD;
          -  Participants with a history of other diseases besides dermatologic disorders (eg,&#xD;
             other autoimmune diseases) taking treatments that could complicate assessments.&#xD;
&#xD;
          -  Participants with cytopenias at screening, defined as:&#xD;
&#xD;
               -  Leukocytes &lt; 3.0 × 10^9/L.&#xD;
&#xD;
               -  Neutrophils &lt; lower limit of normal.&#xD;
&#xD;
               -  Hemoglobin &lt; 10 g/dL.&#xD;
&#xD;
               -  Lymphocytes &lt; 0.8 × 10^9/L&#xD;
&#xD;
               -  Platelets &lt; 100 × 10^9/L.&#xD;
&#xD;
          -  Participants with severely impaired liver function (Child-Pugh Class C) or end-stage&#xD;
             renal disease (ESRD) on dialysis or at least 1 of the following:&#xD;
&#xD;
               -  Serum creatinine &gt; 1.5 mg/dL.&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper&#xD;
                  limit of normal.&#xD;
&#xD;
          -  Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole&#xD;
             within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit&#xD;
             (topical agents with limited systemic availability are permitted).&#xD;
&#xD;
          -  Participants who have previously received Janus kinase (JAK) inhibitors, systemic or&#xD;
             topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib,&#xD;
             pacritinib).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Kuligowski, MD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB DERMATOLOGY, 2000 6th Avenue South</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce</name>
      <address>
        <city>Bryant</city>
        <state>Arkansas</state>
        <zip>72022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENCINO RESEARCH CENTER, 16133 Ventura Blvd</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SAN LUIS DERMATOLOGY AND LASER CLINIC, 15 Santa Rosa Street</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEW ENGLAND RESEARCH ASSOCIATES LLC, 5520 Park Avenue</name>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <zip>06611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS RESEARCH, 2241 Green Valley Road</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>THE INDIANA CLINICAL TRIALS CENTER, 824 Edwards Drive</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMRESEARCH, 1169 Eastern Parkway 2310</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS RESEARCH, 3810 Springhurst Blvd</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACTIVMED PRACTICES &amp; RESEARCH, INC, 138 Conant Street</name>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TUFTS MEDICAL CENTER, 800 Washington Street</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HENRY FORD HOSPITAL, 3031 West Grand Blvd</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WASHINGTON UNIVERSITY - DERMATOLOGY, 4921 Parkview Place</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WASHINGTON UNIVERSITY - DERMATOLOGY, 969 Mason Road</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACTIVMED PRACTICES AND RESEARCH, INC, 110 Corporate Drive</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HASSMAN RESEARCH INSTITUTE, LLC, 175 Cross Keys Road</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMATOLOGY CONSULTING SERVICES, PLLC, 2444 North Main Street</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WAKE RESEARCH ASSOCIATES LLC, 3100 Duraleigh Road</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMATOLOGISTS OF GREATER COLUMBUS, 2359 East Main Street</name>
      <address>
        <city>Bexley</city>
        <state>Ohio</state>
        <zip>43209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RAPID MEDICAL RESEARCH, INC, 3619 Park East Drive</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTRAL SOONER RESEARCH, 900 North Porter</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PARISH DERMATOLOGY, INC, 1845 Walnut Street</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PEAK RESEARCH LLC, 2589 Washington Rd</name>
      <address>
        <city>Upper Saint Clair</city>
        <state>Pennsylvania</state>
        <zip>15241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ARLINGTON RESEARCH CENTER, INC, 711 East Lamar Blvd</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMRESEARCH INC., 8140 North Mopac Expressway</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J&amp;S STUDIES, INC, 1710 Crescent Pointe Pkwy</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTER FOR CLINICAL STUDIES (CCS), 1401 Binz</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUZANNE BRUCE AND ASSOCIATES, PA, 1900 St. James Place</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLINICAL TRIALS OF TEXAS, INC, 7940 Floyd Curl Drive</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMATOLOGY CLINICAL RESEARCH CENTER OF SAN ANTONIO, 7810 Louis Pasteur</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTER FOR CLINICAL STUDIES, 451 North Texas Avenue</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHARLOTTESVILLE DERMATOLOGY, 600 Peter Jefferson Parkway</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INSTITUTE FOR SKIN ADVANCEMENT, 4935 40th Avenue Nw</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3A 2N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DR. CHIH-HO HONG MEDICAL INC., 15300 105 Avenue</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3R 6A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WISEMAN DERMATOLOGY RESEARCH INC, 6 - 1170 Taylor Avenue</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3M 3Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCA MEDICAL RESEARCH, 95 Bayly Street West</name>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <zip>L1S 7K8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER, 5 Quarry Ridge Road</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M 7G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LYNDERM RESEARCH INC, 25 Main Street Markham North</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P 1X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DERMEDGE RESEARCH INC., 333 Lakeshore Road West</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5H 1G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NORTH BAY DERMATOLOGY CENTRE, 500 Cassells Street</name>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <zip>P1B 3Z7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RESEARCH BY ICLS, 1344 Cornwall Road</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6J 7W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OFFICE OF DR. MICHAEL ROBERN, 1 Centrepointe Drive</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K2G 6E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SKIN CENTRE FOR DERMATOLOGY, 775 Monaghan Road</name>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <zip>K9J 5K2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>YORK DERMATOLOGY CENTER, 250 Harding Blvd West</name>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <zip>L4C 9M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RESEARCH TORONTO, 208 Bloor Street West</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5Sz 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>K. PAPP CLINICAL RESEARCH, 135 Union Street East</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>XLR8 MEDICAL RESEARCH, 2425 Tecumseh Road East</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 1E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WINDSOR CLINICAL RESEARCH INC, 2224 Walker Road</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 5L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLINIQUE DERMATOLOGIQUE DE SAINT-JEROME, 555 Boul. Saint-antoine</name>
      <address>
        <city>Saint-jerome</city>
        <state>Quebec</state>
        <zip>J7Z 3B8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>January 25, 2021</results_first_submitted>
  <results_first_submitted_qc>March 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 9, 2021</results_first_posted>
  <disposition_first_submitted>January 25, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>January 25, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 29, 2019</disposition_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic dermatitis</keyword>
  <keyword>eczema</keyword>
  <keyword>pruritus</keyword>
  <keyword>Janus kinase (JAK) inhibitors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03011892/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03011892/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 307 participants were randomized and 306 were treated at 50 study centers in the United States and Canada from 9 January 2017 to 12 March 2018.</recruitment_details>
      <pre_assignment_details>307 participants randomized to 6 treatment groups (ruxolitinib cream 1.5% BID, or QD, 0.5% or 0.15% QD, vehicle BID, &amp; TAC 0.1% BID). Participants applied blinded study drug for 8 weeks, TAC 0.1% BID for 4 weeks followed by vehicle BID for 4 weeks in DB period. After DB period, participants who met criteria (compliant with the protocol and no safety concerns) offered OL treatment with ruxolitinib 1.5% BID for 4 weeks. Out of 261 participants who completed DB Period, 252 entered the OL Period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Double Blind (DB): Vehicle BID</title>
          <description>Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.</description>
        </group>
        <group group_id="P2">
          <title>DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID</title>
          <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
        </group>
        <group group_id="P3">
          <title>DB: Ruxolitinib 0.15% Once Daily (QD)</title>
          <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
        </group>
        <group group_id="P4">
          <title>DB: Ruxolitinib 0.5% QD</title>
          <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
        </group>
        <group group_id="P5">
          <title>DB: Ruxolitinib 1.5% QD</title>
          <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
        </group>
        <group group_id="P6">
          <title>DB: Ruxolitinib 1.5% BID</title>
          <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
        </group>
        <group group_id="P7">
          <title>Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID</title>
          <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="P8">
          <title>OL: TAC BID/ Vehicle BID to Ruxolitinib 1.5% BID</title>
          <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="P9">
          <title>OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID</title>
          <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="P10">
          <title>OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID</title>
          <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="P11">
          <title>OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID</title>
          <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="P12">
          <title>OL: Ruxolitinib 1.5% Cream BID for 8 Weeks in DB Period.</title>
          <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double Blind (DB) Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="51"/>
                <participants group_id="P5" count="52"/>
                <participants group_id="P6" count="50"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated in DB Period</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="51"/>
                <participants group_id="P5" count="51"/>
                <participants group_id="P6" count="50"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Treatment Through Week 4</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="48"/>
                <participants group_id="P4" count="47"/>
                <participants group_id="P5" count="49"/>
                <participants group_id="P6" count="49"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="44"/>
                <participants group_id="P5" count="45"/>
                <participants group_id="P6" count="45"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open Label (OL) Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="41"/>
                <participants group_id="P8" count="40"/>
                <participants group_id="P9" count="45"/>
                <participants group_id="P10" count="41"/>
                <participants group_id="P11" count="42"/>
                <participants group_id="P12" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="34"/>
                <participants group_id="P8" count="37"/>
                <participants group_id="P9" count="43"/>
                <participants group_id="P10" count="41"/>
                <participants group_id="P11" count="40"/>
                <participants group_id="P12" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="7"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-Treat (ITT) population included all participants who are randomized to the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Double Blind (DB): Vehicle BID</title>
          <description>Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.</description>
        </group>
        <group group_id="B2">
          <title>DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID</title>
          <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
        </group>
        <group group_id="B3">
          <title>DB: Ruxolitinib 0.15% Once Daily (QD)</title>
          <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
        </group>
        <group group_id="B4">
          <title>DB : Ruxolitinib 0.5% QD</title>
          <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
        </group>
        <group group_id="B5">
          <title>DB : Ruxolitinib 1.5% QD</title>
          <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
        </group>
        <group group_id="B6">
          <title>DB : Ruxolitinib 1.5% Cream Twice Daily (BID)</title>
          <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="52"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="51"/>
            <count group_id="B5" value="52"/>
            <count group_id="B6" value="50"/>
            <count group_id="B7" value="307"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.8" spread="15.04"/>
                    <measurement group_id="B2" value="38.5" spread="16.19"/>
                    <measurement group_id="B3" value="38.4" spread="13.83"/>
                    <measurement group_id="B4" value="38.6" spread="13.73"/>
                    <measurement group_id="B5" value="39.1" spread="14.54"/>
                    <measurement group_id="B6" value="39.0" spread="15.72"/>
                    <measurement group_id="B7" value="38.1" spread="14.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="31"/>
                    <measurement group_id="B6" value="24"/>
                    <measurement group_id="B7" value="168"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="26"/>
                    <measurement group_id="B7" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="48"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="47"/>
                    <measurement group_id="B7" value="285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White/Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="24"/>
                    <measurement group_id="B6" value="33"/>
                    <measurement group_id="B7" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African-American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID</title>
        <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID or ruxolitinib 1.5% BID, with available data were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID</title>
          <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
          <population>Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID or ruxolitinib 1.5% BID, with available data were included in the analysis.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.90" spread="6.65"/>
                    <measurement group_id="O2" value="-71.57" spread="6.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>MMRM</method>
            <param_type>Difference in Least Square (LS) Mean</param_type>
            <param_value>-59.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-77.85</ci_lower_limit>
            <ci_upper_limit>-41.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID</title>
        <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD in the DB Period, with available data were included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID</title>
          <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
          <population>Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD in the DB Period, with available data were included in the analysis</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.90" spread="6.65"/>
                    <measurement group_id="O2" value="-44.92" spread="6.47"/>
                    <measurement group_id="O3" value="-52.80" spread="6.52"/>
                    <measurement group_id="O4" value="-66.72" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DB: Vehicle BID, Ruxolitinib 0.15% QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-33.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.27</ci_lower_limit>
            <ci_upper_limit>-14.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-40.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-59.23</ci_lower_limit>
            <ci_upper_limit>-22.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-54.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-72.93</ci_lower_limit>
            <ci_upper_limit>-36.70</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle</title>
        <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>Participants from ITT population, all participants who are randomized to TAC 0.1% BID followed by vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD/BID in the DB Period, with available data were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: TAC 0.1% BID/Vehicle Cream BID</title>
            <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O5">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle</title>
          <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
          <population>Participants from ITT population, all participants who are randomized to TAC 0.1% BID followed by vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD/BID in the DB Period, with available data were included in the analysis.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-59.54" spread="6.53"/>
                    <measurement group_id="O2" value="-44.92" spread="6.47"/>
                    <measurement group_id="O3" value="-52.80" spread="6.52"/>
                    <measurement group_id="O4" value="-66.72" spread="6.36"/>
                    <measurement group_id="O5" value="-71.57" spread="6.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.15% QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1127</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>14.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.47</ci_lower_limit>
            <ci_upper_limit>32.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.5% QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4659</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>6.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.44</ci_lower_limit>
            <ci_upper_limit>24.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 1.5% QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4320</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-7.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.13</ci_lower_limit>
            <ci_upper_limit>10.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1903</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-12.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.05</ci_lower_limit>
            <ci_upper_limit>6.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8</title>
        <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
        <time_frame>Baseline, Week 2 and 8</time_frame>
        <population>ITT Population included all participants who are randomized to Vehicle BID, TAC 0.1% BID/Vehicle Cream BID, Ruxolitinib 0.15%, 0.5%, 1.5%, 1.5% QD/BID in the DB Period. The overall number of participants analyzed are participants with data available for analysis for this Outcome Measure and &quot;n&quot; signifies number of participants with data available at specific timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: TAC 0.1% BID/Vehicle Cream BID</title>
            <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O5">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O6">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8</title>
          <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
          <population>ITT Population included all participants who are randomized to Vehicle BID, TAC 0.1% BID/Vehicle Cream BID, Ruxolitinib 0.15%, 0.5%, 1.5%, 1.5% QD/BID in the DB Period. The overall number of participants analyzed are participants with data available for analysis for this Outcome Measure and &quot;n&quot; signifies number of participants with data available at specific timepoint.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="52"/>
                <count group_id="O6" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="51"/>
                    <count group_id="O6" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.84" spread="5.34"/>
                    <measurement group_id="O2" value="-39.94" spread="5.29"/>
                    <measurement group_id="O3" value="-29.96" spread="5.23"/>
                    <measurement group_id="O4" value="-45.88" spread="5.41"/>
                    <measurement group_id="O5" value="-49.88" spread="5.18"/>
                    <measurement group_id="O6" value="-52.68" spread="5.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="46"/>
                    <count group_id="O6" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.86" spread="7.09"/>
                    <measurement group_id="O2" value="-58.02" spread="6.94"/>
                    <measurement group_id="O3" value="-50.24" spread="6.82"/>
                    <measurement group_id="O4" value="-58.37" spread="6.93"/>
                    <measurement group_id="O5" value="-67.05" spread="6.72"/>
                    <measurement group_id="O6" value="-79.01" spread="6.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0009</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-25.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.84</ci_lower_limit>
            <ci_upper_limit>-10.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-47.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-62.64</ci_lower_limit>
            <ci_upper_limit>-33.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-41.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-56.00</ci_lower_limit>
            <ci_upper_limit>-26.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-45.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-59.69</ci_lower_limit>
            <ci_upper_limit>-30.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1806</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>9.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.66</ci_lower_limit>
            <ci_upper_limit>24.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4333</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-5.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.82</ci_lower_limit>
            <ci_upper_limit>8.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1805</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-9.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.51</ci_lower_limit>
            <ci_upper_limit>4.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0895</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-12.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.45</ci_lower_limit>
            <ci_upper_limit>1.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0042</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-28.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.74</ci_lower_limit>
            <ci_upper_limit>-9.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-36.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-56.03</ci_lower_limit>
            <ci_upper_limit>-17.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-45.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-57.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-76.53</ci_lower_limit>
            <ci_upper_limit>-37.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4243</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>7.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.37</ci_lower_limit>
            <ci_upper_limit>26.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9715</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.65</ci_lower_limit>
            <ci_upper_limit>18.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3507</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-9.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.05</ci_lower_limit>
            <ci_upper_limit>9.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0320</p_value>
            <method>MMRM</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-20.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.15</ci_lower_limit>
            <ci_upper_limit>-1.82</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8</title>
        <description>The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).</description>
        <time_frame>Week 2, 4 and 8</time_frame>
        <population>ITT Population included all participants who are randomized to the study.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: TAC 0.1% BID/Vehicle Cream BID</title>
            <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O5">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O6">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8</title>
          <description>The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).</description>
          <population>ITT Population included all participants who are randomized to the study.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="52"/>
                <count group_id="O6" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5"/>
                    <measurement group_id="O2" value="43.1"/>
                    <measurement group_id="O3" value="31.4"/>
                    <measurement group_id="O4" value="57.1"/>
                    <measurement group_id="O5" value="50.0"/>
                    <measurement group_id="O6" value="52.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="52.9"/>
                    <measurement group_id="O4" value="58.8"/>
                    <measurement group_id="O5" value="73.1"/>
                    <measurement group_id="O6" value="78.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9"/>
                    <measurement group_id="O2" value="60.8"/>
                    <measurement group_id="O3" value="54.9"/>
                    <measurement group_id="O4" value="62.7"/>
                    <measurement group_id="O5" value="69.2"/>
                    <measurement group_id="O6" value="76.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in EASI Score at Week 4</title>
        <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: TAC 0.1% BID/Vehicle Cream BID</title>
            <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O5">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O6">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in EASI Score at Week 4</title>
          <description>EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.</description>
          <population>ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at Week 4.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="49"/>
                <count group_id="O6" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.5" spread="65.71"/>
                    <measurement group_id="O2" value="-59.8" spread="35.71"/>
                    <measurement group_id="O3" value="-45.4" spread="53.96"/>
                    <measurement group_id="O4" value="-52.2" spread="48.32"/>
                    <measurement group_id="O5" value="-67.0" spread="26.28"/>
                    <measurement group_id="O6" value="-71.6" spread="25.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Achieve EASI-50</title>
        <description>Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.</description>
        <time_frame>From Baseline to Week 8</time_frame>
        <population>ITT population included all participants who are randomized to the study.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: TAC 0.1% BID/Vehicle Cream BID</title>
            <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O5">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O6">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Achieve EASI-50</title>
          <description>Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.</description>
          <population>ITT population included all participants who are randomized to the study.</population>
          <units>week</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="52"/>
                <count group_id="O6" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O3" value="4" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O4" value="2" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O5" value="2" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O6" value="2" lower_limit="0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8</title>
        <description>IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.</description>
        <time_frame>Week 2, 4 and 8</time_frame>
        <population>ITT Population included all participants who are randomized to the study.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: TAC 0.1% BID/Vehicle Cream BID</title>
            <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O5">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O6">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8</title>
          <description>IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.</description>
          <population>ITT Population included all participants who are randomized to the study.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="52"/>
                <count group_id="O6" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="11.8"/>
                    <measurement group_id="O3" value="5.9"/>
                    <measurement group_id="O4" value="4.1"/>
                    <measurement group_id="O5" value="13.5"/>
                    <measurement group_id="O6" value="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="25.5"/>
                    <measurement group_id="O3" value="9.8"/>
                    <measurement group_id="O4" value="13.7"/>
                    <measurement group_id="O5" value="21.2"/>
                    <measurement group_id="O6" value="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="17.6"/>
                    <measurement group_id="O3" value="15.7"/>
                    <measurement group_id="O4" value="31.4"/>
                    <measurement group_id="O5" value="30.8"/>
                    <measurement group_id="O6" value="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8</title>
        <description>The Itch NRS is a once-per-24 hours (&quot;daily&quot;) participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.</description>
        <time_frame>Baseline, Week 2, 4 and 8</time_frame>
        <population>ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at specified time-point and 'n' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: TAC 0.1% BID/ Vehicle BID</title>
            <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O5">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O6">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8</title>
          <description>The Itch NRS is a once-per-24 hours (&quot;daily&quot;) participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.</description>
          <population>ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at specified time-point and 'n' signifies number of participants evaluable for this outcome measure.</population>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="46"/>
                <count group_id="O4" value="48"/>
                <count group_id="O5" value="48"/>
                <count group_id="O6" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="48"/>
                    <count group_id="O5" value="48"/>
                    <count group_id="O6" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.11"/>
                    <measurement group_id="O2" value="5.2" spread="2.22"/>
                    <measurement group_id="O3" value="6.1" spread="2.23"/>
                    <measurement group_id="O4" value="6.2" spread="1.71"/>
                    <measurement group_id="O5" value="6.2" spread="2.14"/>
                    <measurement group_id="O6" value="5.9" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="44"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="45"/>
                    <count group_id="O6" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.46"/>
                    <measurement group_id="O2" value="-2.2" spread="1.75"/>
                    <measurement group_id="O3" value="-1.9" spread="1.97"/>
                    <measurement group_id="O4" value="-2.5" spread="2.23"/>
                    <measurement group_id="O5" value="-3.1" spread="2.14"/>
                    <measurement group_id="O6" value="-3.7" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="41"/>
                    <count group_id="O4" value="40"/>
                    <count group_id="O5" value="44"/>
                    <count group_id="O6" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.79"/>
                    <measurement group_id="O2" value="-2.5" spread="1.94"/>
                    <measurement group_id="O3" value="-2.3" spread="2.08"/>
                    <measurement group_id="O4" value="-2.6" spread="2.22"/>
                    <measurement group_id="O5" value="-3.3" spread="2.24"/>
                    <measurement group_id="O6" value="-4.0" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="38"/>
                    <count group_id="O4" value="38"/>
                    <count group_id="O5" value="39"/>
                    <count group_id="O6" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.13"/>
                    <measurement group_id="O2" value="-2.2" spread="1.86"/>
                    <measurement group_id="O3" value="-3.0" spread="2.49"/>
                    <measurement group_id="O4" value="-2.9" spread="2.41"/>
                    <measurement group_id="O5" value="-3.8" spread="2.39"/>
                    <measurement group_id="O6" value="-4.2" spread="2.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With At Least One Adverse Event (AEs) and as Per Severity</title>
        <description>AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>Safety Population in the DB treatment period included all enrolled participants who applied at least 1 dose of ruxolitinib cream, triamcinolone cream, or vehicle cream.</population>
        <group_list>
          <group group_id="O1">
            <title>DB: Vehicle BID</title>
            <description>Participants applied vehicle cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O2">
            <title>DB: TAC 0.1% BID/Vehicle Cream BID</title>
            <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.</description>
          </group>
          <group group_id="O3">
            <title>DB: Ruxolitinib 0.15% QD</title>
            <description>Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O4">
            <title>DB: Ruxolitinib 0.5% QD</title>
            <description>Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O5">
            <title>DB: Ruxolitinib 1.5% QD</title>
            <description>Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.</description>
          </group>
          <group group_id="O6">
            <title>DB: Ruxolitinib 1.5% BID</title>
            <description>Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.</description>
          </group>
          <group group_id="O7">
            <title>OL: Vehicle BID to Ruxolitinib 1.5% BID</title>
            <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID</title>
            <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
          </group>
          <group group_id="O9">
            <title>OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID</title>
            <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
          </group>
          <group group_id="O10">
            <title>OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID</title>
            <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
          </group>
          <group group_id="O11">
            <title>OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID</title>
            <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
          </group>
          <group group_id="O12">
            <title>OL: Ruxolitinib 1.5% BID</title>
            <description>Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With At Least One Adverse Event (AEs) and as Per Severity</title>
          <description>AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.</description>
          <population>Safety Population in the DB treatment period included all enrolled participants who applied at least 1 dose of ruxolitinib cream, triamcinolone cream, or vehicle cream.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="51"/>
                <count group_id="O6" value="50"/>
                <count group_id="O7" value="41"/>
                <count group_id="O8" value="40"/>
                <count group_id="O9" value="45"/>
                <count group_id="O10" value="41"/>
                <count group_id="O11" value="42"/>
                <count group_id="O12" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Least One AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="12"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="11"/>
                    <measurement group_id="O9" value="11"/>
                    <measurement group_id="O10" value="8"/>
                    <measurement group_id="O11" value="11"/>
                    <measurement group_id="O12" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 and Higher</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 24</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Vehicle BID</title>
          <description>Participants applied vehicle cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Triamcinolone 0.1% BID for 4 Weeks Then 4 Week Vehicle BID</title>
          <description>Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks. At Week 8, participants who met criteria were offered open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="E3">
          <title>INCB018424 0.15% QD</title>
          <description>Participants applied Ruxolitinib 0.15% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="E4">
          <title>INCB018424 0.5% QD</title>
          <description>Participants applied Ruxolitinib 0.5% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="E5">
          <title>INCB018424 1.5% QD</title>
          <description>Participants applied Ruxolitinib 1.5% QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
        <group group_id="E6">
          <title>INCB018424 1.5% BID</title>
          <description>Participants applied Ruxolitinib 1.5% cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="259"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="259"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="259"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="259"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E6" events="17" subjects_affected="13" subjects_at_risk="259"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="8" subjects_affected="7" subjects_at_risk="259"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="259"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Clinical Study Agreement</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Incyte Corporation</organization>
      <phone>1-855-463-3463</phone>
      <email>medinfo@incyte.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03011892
org study id: INCB 18424-206
nct id: NCT03011892
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream
      once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with
      vehicle cream BID.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID
time frame: Baseline and Week 4
description: EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
measure: Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID
time frame: Baseline and Week 4
description: EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
measure: Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle
time frame: Baseline and Week 4
description: EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
measure: Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
time frame: Baseline, Week 2 and 8
description: EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
measure: Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
time frame: Week 2, 4 and 8
description: The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).
measure: Percentage Change From Baseline in EASI Score at Week 4
time frame: Baseline and Week 4
description: EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
measure: Time to Achieve EASI-50
time frame: From Baseline to Week 8
description: Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.
measure: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
time frame: Week 2, 4 and 8
description: IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
measure: Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
time frame: Baseline, Week 2, 4 and 8
description: The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.
measure: Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
time frame: Up to Week 24
description: AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.
arm group label: Double Blind (DB): Vehicle BID
arm group type: Placebo Comparator
description: Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
arm group label: DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
arm group type: Active Comparator
description: Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
arm group label: DB: Ruxolitinib 0.15% Once Daily (QD)
arm group type: Experimental
description: Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
arm group label: DB: Ruxolitinib 0.5% QD
arm group type: Experimental
description: Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
arm group label: DB: Ruxolitinib 1.5% QD
arm group type: Experimental
description: Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
arm group label: DB: Ruxolitinib 1.5% BID
arm group type: Experimental
description: Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
arm group label: Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID
arm group type: Placebo Comparator
description: Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
arm group label: OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID
arm group type: Active Comparator
description: Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
arm group label: OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
arm group type: Experimental
description: Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
arm group label: OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
arm group type: Experimental
description: Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
arm group label: OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
arm group type: Experimental
description: Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
arm group label: OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID
arm group type: Experimental
description: Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
intervention type: Drug
intervention name: Ruxolitinib 0.15% Cream QD
description: Ruxolitinib 0.15% cream QD
arm group label: DB: Ruxolitinib 0.15% Once Daily (QD)
other name: INCB018424
intervention type: Drug
intervention name: Ruxolitinib 0.5% Cream QD
description: Ruxolitinib 0.5% cream QD
arm group label: DB: Ruxolitinib 0.5% QD
other name: INCB018424
intervention type: Drug
intervention name: Ruxolitinib 1.5% Cream QD
description: Ruxolitinib 1.5% cream QD
arm group label: DB: Ruxolitinib 1.5% QD
other name: INCB018424
intervention type: Drug
intervention name: Ruxolitinib 1.5% Cream BID
description: Ruxolitinib 1.5% cream BID
arm group label: DB: Ruxolitinib 1.5% BID
arm group label: OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
arm group label: OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
arm group label: OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID
arm group label: OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
arm group label: OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID
arm group label: Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID
other name: INCB018424
intervention type: Drug
intervention name: Triamcinolone 0.1% Cream BID
description: Triamcinolone 0.1% cream BID
arm group label: DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
intervention type: Drug
intervention name: Vehicle Cream BID
description: Vehicle cream BID
arm group label: DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
arm group label: Double Blind (DB): Vehicle BID
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Michael Kuligowski, MD
role: Study Director
affiliation: Incyte Corporation
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Triamcinolone
sharing ipd: No
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