<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/NCT03832010</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00178631</org_study_id>
    <nct_id>NCT03832010</nct_id>
  </id_info>
  <brief_title>Steroid-reducing Effects of Crisaborole</brief_title>
  <official_title>Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atopic dermatitis, or eczema, is a chronic skin condition affecting many children.&#xD;
      Crisaborole is a non-steroid topical medication which is FDA approved for children aged 2 and&#xD;
      older for eczema. This research study seeks to investigate whether crisaborole reduces&#xD;
      topical steroid use in children with atopic dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children.&#xD;
      Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active&#xD;
      inflammatory disease. Side effects of TCS range from cutaneous atrophy to&#xD;
      hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often&#xD;
      lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs)&#xD;
      are currently recommended as steroid-reducing agents, especially on sensitive areas such as&#xD;
      the face and skin folds. However, TCis are associated with burning reactions and come with&#xD;
      black box warnings.&#xD;
&#xD;
      Crisaborole (Eucrisa), the newest topical prescription option for AD, is a&#xD;
      phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with&#xD;
      mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole&#xD;
      makes for an alternative topical option to its predecessors. However, corresponding data are&#xD;
      lacking. It would be of great interest to patients, patients' families and providers if&#xD;
      crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The&#xD;
      investigators therefore propose a proof-of-concept study to investigate whether crisaborole&#xD;
      can serve as an effective steroid-reducing agent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 17, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 4</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Steroid usage quantity</measure>
    <time_frame>Day 30</time_frame>
    <description>Steroid usage measured in medication weight (grams)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steroid usage quantity</measure>
    <time_frame>Day 90</time_frame>
    <description>Steroid usage measured in medication weight (grams)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steroid usage frequency</measure>
    <time_frame>Day 30</time_frame>
    <description>Steroid usage measured in diary entries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steroid usage frequency</measure>
    <time_frame>Day 90</time_frame>
    <description>Steroid usage measured in diary entries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steroid refills</measure>
    <time_frame>Day 30</time_frame>
    <description>Steroid usage measured in number of refills</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steroid refills</measure>
    <time_frame>Day 90</time_frame>
    <description>Steroid usage measured in number of refills</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eczema severity as assessed by SCORing Atopic Dermatitis (SCORAD) score</measure>
    <time_frame>Day 0</time_frame>
    <description>Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Highest score corresponds with highest severity of eczema. Lowest score corresponds with lowest severity of eczema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eczema severity assessed by SCORAD score</measure>
    <time_frame>Day 30</time_frame>
    <description>Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eczema severity assessed by SCORAD score</measure>
    <time_frame>Day 90</time_frame>
    <description>Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for participant as assessed by Children's Dermatology Life Quality Index</measure>
    <time_frame>Day 0</time_frame>
    <description>Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for participant as assessed by Dermatology Life Quality Index</measure>
    <time_frame>Day 0</time_frame>
    <description>Dermatology Life Quality Index (ages 16 or older). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for participant as assessed by Children's Dermatology Life Quality Index</measure>
    <time_frame>Day 30</time_frame>
    <description>Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for participant as assessed by Dermatology Life Quality Index</measure>
    <time_frame>Day 30</time_frame>
    <description>Dermatology Life Quality Index (ages 16 or older). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for participant as assessed by Children's Dermatology Life Quality Index</measure>
    <time_frame>Day 90</time_frame>
    <description>Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for participant as assessed by Dermatology Life Quality Index</measure>
    <time_frame>Day 90</time_frame>
    <description>Dermatology Life Quality Index (ages 16 or older). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for family as assessed by Dermatitis Family Impact Questionnaire</measure>
    <time_frame>Day 0</time_frame>
    <description>Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for family as assessed by Dermatitis Family Impact Questionnaire</measure>
    <time_frame>Day 30</time_frame>
    <description>Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life for family as assessed by Dermatitis Family Impact Questionnaire</measure>
    <time_frame>Day 90</time_frame>
    <description>Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of itching as assessed by Pruritus score</measure>
    <time_frame>Day 0</time_frame>
    <description>Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of itching as assessed by Pruritus score</measure>
    <time_frame>Day 30</time_frame>
    <description>Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of itching as assessed by Pruritus score</measure>
    <time_frame>Day 90</time_frame>
    <description>Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Atopic Dermatitis</condition>
  <condition>Eczema</condition>
  <arm_group>
    <arm_group_label>Crisaborole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Crisaborole</intervention_name>
    <description>Participants will be instructed to apply crisaborole to affected areas with eczema.</description>
    <arm_group_label>Crisaborole</arm_group_label>
    <other_name>Eucrisa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortisone Ointment</intervention_name>
    <description>Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Crisaborole</arm_group_label>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone ointment</intervention_name>
    <description>Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Crisaborole</arm_group_label>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aquaphor</intervention_name>
    <description>Participants will be instructed to moisturize all over the body with Aquaphor.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Crisaborole</arm_group_label>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Children aged 2 or older (&lt;18).&#xD;
&#xD;
          -  Diagnosed with atopic dermatitis.&#xD;
&#xD;
          -  At baseline, AD is mild to moderate (score of 2 [mild] to 3 [moderate]) on the&#xD;
             Investigator's Global Assessment scale (IGA; scores range 0-4, higher indicates&#xD;
             greater severity).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Known allergy to a constituent of the studied products (crisaborole, vehicle,&#xD;
             Aquaphor, topical steroids [hydrocortisone 2.5% ointment and triamcinolone acetonide&#xD;
             0.1% ointment]).&#xD;
&#xD;
          -  At baseline, AD is severe (score of 4 [severe] on the IGA scale).&#xD;
&#xD;
          -  Medical problems which interfere with completion of protocols in this study.&#xD;
&#xD;
          -  Pregnant or lactating females. (Females who have experienced menarche will be required&#xD;
             to take a urine pregnancy test.)&#xD;
&#xD;
          -  Participant is enrolled in another research study.&#xD;
&#xD;
          -  Participant or participant's guardian(s) are unable to follow instructions as required&#xD;
             in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Grossberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11. Erratum In: J Am Acad Dermatol. 2017 Apr;76(4):777.</citation>
    <PMID>27417017</PMID>
  </reference>
  <reference>
    <citation>Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.</citation>
    <PMID>24813302</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Topical steroid</keyword>
  <keyword>Crisaborole</keyword>
  <keyword>Topical calcineurin inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Hydrocortisone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03832010
org study id: IRB00178631
nct id: NCT03832010
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Atopic dermatitis, or eczema, is a chronic skin condition affecting many children.
      Crisaborole is a non-steroid topical medication which is FDA approved for children aged 2 and
      older for eczema. This research study seeks to investigate whether crisaborole reduces
      topical steroid use in children with atopic dermatitis.
Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children.
      Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active
      inflammatory disease. Side effects of TCS range from cutaneous atrophy to
      hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often
      lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs)
      are currently recommended as steroid-reducing agents, especially on sensitive areas such as
      the face and skin folds. However, TCis are associated with burning reactions and come with
      black box warnings.

      Crisaborole (Eucrisa), the newest topical prescription option for AD, is a
      phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with
      mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole
      makes for an alternative topical option to its predecessors. However, corresponding data are
      lacking. It would be of great interest to patients, patients' families and providers if
      crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The
      investigators therefore propose a proof-of-concept study to investigate whether crisaborole
      can serve as an effective steroid-reducing agent.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Steroid usage quantity
time frame: Day 30
description: Steroid usage measured in medication weight (grams)
measure: Steroid usage quantity
time frame: Day 90
description: Steroid usage measured in medication weight (grams)
measure: Steroid usage frequency
time frame: Day 30
description: Steroid usage measured in diary entries
measure: Steroid usage frequency
time frame: Day 90
description: Steroid usage measured in diary entries
measure: Steroid refills
time frame: Day 30
description: Steroid usage measured in number of refills
measure: Steroid refills
time frame: Day 90
description: Steroid usage measured in number of refills
measure: Eczema severity as assessed by SCORing Atopic Dermatitis (SCORAD) score
time frame: Day 0
description: Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Highest score corresponds with highest severity of eczema. Lowest score corresponds with lowest severity of eczema.
measure: Eczema severity assessed by SCORAD score
time frame: Day 30
description: Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.
measure: Eczema severity assessed by SCORAD score
time frame: Day 90
description: Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.
measure: Quality of life for participant as assessed by Children's Dermatology Life Quality Index
time frame: Day 0
description: Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Quality of life for participant as assessed by Dermatology Life Quality Index
time frame: Day 0
description: Dermatology Life Quality Index (ages 16 or older). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Quality of life for participant as assessed by Children's Dermatology Life Quality Index
time frame: Day 30
description: Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Quality of life for participant as assessed by Dermatology Life Quality Index
time frame: Day 30
description: Dermatology Life Quality Index (ages 16 or older). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Quality of life for participant as assessed by Children's Dermatology Life Quality Index
time frame: Day 90
description: Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Quality of life for participant as assessed by Dermatology Life Quality Index
time frame: Day 90
description: Dermatology Life Quality Index (ages 16 or older). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Quality of life for family as assessed by Dermatitis Family Impact Questionnaire
time frame: Day 0
description: Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Quality of life for family as assessed by Dermatitis Family Impact Questionnaire
time frame: Day 30
description: Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Quality of life for family as assessed by Dermatitis Family Impact Questionnaire
time frame: Day 90
description: Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
measure: Severity of itching as assessed by Pruritus score
time frame: Day 0
description: Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
measure: Severity of itching as assessed by Pruritus score
time frame: Day 30
description: Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
measure: Severity of itching as assessed by Pruritus score
time frame: Day 90
description: Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
arm group label: Crisaborole
arm group type: Active Comparator
description: Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
arm group label: Vehicle
arm group type: Placebo Comparator
description: Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
arm group label: Control
arm group type: Sham Comparator
description: Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
intervention type: Drug
intervention name: Crisaborole
description: Participants will be instructed to apply crisaborole to affected areas with eczema.
arm group label: Crisaborole
other name: Eucrisa
intervention type: Drug
intervention name: Hydrocortisone Ointment
description: Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
arm group label: Control
arm group label: Crisaborole
arm group label: Vehicle
intervention type: Drug
intervention name: Triamcinolone ointment
description: Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
arm group label: Control
arm group label: Crisaborole
arm group label: Vehicle
intervention type: Drug
intervention name: Aquaphor
description: Participants will be instructed to moisturize all over the body with Aquaphor.
arm group label: Control
arm group label: Crisaborole
arm group label: Vehicle
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anna Grossberg, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
citation: Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11. Erratum In: J Am Acad Dermatol. 2017 Apr;76(4):777.
PMID: 27417017
citation: Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
PMID: 24813302
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Triamcinolone
mesh term: Hydrocortisone
sharing ipd: No