<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/NCT04445987</url>
  </required_header>
  <id_info>
    <org_study_id>ARQ-154-214</org_study_id>
    <nct_id>NCT04445987</nct_id>
  </id_info>
  <brief_title>Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis</brief_title>
  <official_title>A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arcutis Biotherapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arcutis Biotherapeutics, Inc.</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>
      Open-label, long-term safety study of ARQ-154 foam 0.3% in subjects with seborrheic&#xD;
      dermatitis involving up to 20% total Body Surface Area (BSA). Study medication will be&#xD;
      applied by the qualifying subjects topically once daily for 52 weeks. Cohort 1 subjects are&#xD;
      rollover subjects from a prior ARQ-154 trial. Cohort 2 include treatment naive subjects.&#xD;
      Periodic clinic visits will include assessments for clinical safety, application site&#xD;
      reactions, and disease improvement or progression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">November 19, 2022</completion_date>
  <primary_completion_date type="Actual">November 19, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Emergent Adverse Events</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Occurrence of treatment emergent adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serious Adverse Events</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Occurrence of treatment serious adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator Global Assessment</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Achievement of an IGA score of 'completely clear' or 'almost clear' as observed over time. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Global Assessment</measure>
    <time_frame>52 Weeks</time_frame>
    <description>A 2-grade improvement in IGA from Baseline as observed over time. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Global Assessment</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Achievement of an IGA score of 'completely clear' or 'almost clear' plus a 2-grade improvement in IGA from baseline as observed at Week 12, Week 24. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Duration of IGA Success, defined as the time from the first observation of IGA Success to the last time a subject's disease response meets the criteria for IGA Success. The duration of IGA Success for subjects who end treatment in IGA Success will be censored at the last disease assessment date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Free Interval</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Treatment-free interval, defined among subjects who achieve a 'completely clear' IGA and stop treatment to all lesions, as the time from attainment of a score of 'clear' to re-starting study drug.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">408</enrollment>
  <condition>Seborrheic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Long-term safety of ARQ-154</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open-label, Long-term Safety of ARQ-154</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ARQ-154</intervention_name>
    <description>ARQ-154 foam 0.3% applied once daily for 52 weeks</description>
    <arm_group_label>Long-term safety of ARQ-154</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants legally competent to sign and give informed consent or (for adolescents)&#xD;
             assent.&#xD;
&#xD;
          2. Males and females ages 9 years and older (inclusive) at the time of consent.&#xD;
&#xD;
          3. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at&#xD;
             all study visits.&#xD;
&#xD;
          4. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have&#xD;
             undergone surgical sterilization.&#xD;
&#xD;
             Cohort 1 only:&#xD;
&#xD;
          5. Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154&#xD;
             study, successfully completed a prior ARQ-154 study through final visit and are able&#xD;
             to immediately enroll into this long-term safety study on the final visit of the&#xD;
             previous ARQ-154 study.&#xD;
&#xD;
             Cohort 2 subjects that have not participated in a prior ARQ-154 study:&#xD;
&#xD;
          6. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as&#xD;
             determined by the Investigator. Stable disease for the past 4 weeks.&#xD;
&#xD;
          7. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous&#xD;
             areas up to ≤20% BSA involvement.&#xD;
&#xD;
          8. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3')&#xD;
             at Day 1.&#xD;
&#xD;
          9. Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate&#xD;
             ('2') at Day 1.&#xD;
&#xD;
             Cohort 2 subjects that have participated in a prior ARQ-154 study:&#xD;
&#xD;
         10. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as&#xD;
             determined by the Investigator.&#xD;
&#xD;
         11. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous&#xD;
             areas up to ≤20% BSA involvement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Planned excessive exposure of treated area(s) to either natural or artificial&#xD;
             sunlight, tanning bed or other LED.&#xD;
&#xD;
          2. Subjects with any condition on the treatment area which, in the opinion of the&#xD;
             Investigator, could confound efficacy measurements.&#xD;
&#xD;
          3. Subjects unable to apply investigational product to the scalp due to physical&#xD;
             limitation.&#xD;
&#xD;
          4. Known allergies to excipients in ARQ-154 foam.&#xD;
&#xD;
          5. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g.,&#xD;
             indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole,&#xD;
             nefazodone, saquinavir, suboxone and telithromycin during the study period.&#xD;
&#xD;
          6. Known or suspected:&#xD;
&#xD;
               -  severe renal insufficiency or moderate to severe hepatic disorders&#xD;
&#xD;
               -  history of severe depression, suicidal ideation or C-SSRS indicative of suicidal&#xD;
                  ideation, whether lifetime or recent/recurrent.&#xD;
&#xD;
          7. Females who are pregnant, wishing to become pregnant during the study, or are&#xD;
             breast-feeding.&#xD;
&#xD;
          8. Subjects with any serious medical condition or laboratory abnormality that would&#xD;
             prevent study participation or place the subject at significant risk, as determined by&#xD;
             the Investigator.&#xD;
&#xD;
          9. Subjects with a history of chronic alcohol or drugs abuse within 6 months of&#xD;
             initiation of investigational product.&#xD;
&#xD;
         10. Current or a history of cancer within 5 years with the exception of fully treated skin&#xD;
             basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the&#xD;
             cervix.&#xD;
&#xD;
         11. Subjects who are unable to communicate, read or understand the local language, or who&#xD;
             display another condition, which in the Investigator's opinion, makes them unsuitable&#xD;
             for clinical study participation.&#xD;
&#xD;
         12. Subjects who are family members of the clinical study site, clinical study staff, or&#xD;
             sponsor, or family members that live in the same household of enrolled subjects.&#xD;
&#xD;
             Cohort 1 only:&#xD;
&#xD;
         13. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that&#xD;
             precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.&#xD;
&#xD;
         14. Subjects that use any Excluded Medication and Treatments.&#xD;
&#xD;
             Cohort 2 only:&#xD;
&#xD;
         15. Subjects who cannot discontinue treatment with therapies for the treatment of&#xD;
             seborrheic dermatitis prior to the Day 1 visit and during the study according to&#xD;
             Excluded Medications and Treatments.&#xD;
&#xD;
         16. Subjects with PHQ-8 &gt;10 or modified PHQ-A &gt;10 at Screening or Day 1.&#xD;
&#xD;
             Cohort 2 subjects that have participated in a prior ARQ-154 study:&#xD;
&#xD;
         17. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that&#xD;
             precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Berk, MD</last_name>
    <role>Study Director</role>
    <affiliation>Arcutis Biotherapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 59</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 51</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 75</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 19</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 62</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 64</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 21</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 53</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 42</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 57</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 24</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 65</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 12</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 10</name>
      <address>
        <city>Rolling Meadows</city>
        <state>Illinois</state>
        <zip>60008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 22</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 15</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 52</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 28</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 73</name>
      <address>
        <city>Brighton</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 40</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 20</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 58</name>
      <address>
        <city>Fort Gratiot</city>
        <state>Michigan</state>
        <zip>48059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 14</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 50</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 56</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 63</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 55</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 23</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 18</name>
      <address>
        <city>Bexley</city>
        <state>Ohio</state>
        <zip>43209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 29</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 27</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 76</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 13</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 11</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 41</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 25</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 26</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 54</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Biotherapeutics Clinical Site 17</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Dermatitis, Seborrheic</mesh_term>
  </condition_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/NCT04445987
org study id: ARQ-154-214
nct id: NCT04445987
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Open-label, long-term safety study of ARQ-154 foam 0.3% in subjects with seborrheic
      dermatitis involving up to 20% total Body Surface Area (BSA). Study medication will be
      applied by the qualifying subjects topically once daily for 52 weeks. Cohort 1 subjects are
      rollover subjects from a prior ARQ-154 trial. Cohort 2 include treatment naive subjects.
      Periodic clinic visits will include assessments for clinical safety, application site
      reactions, and disease improvement or progression.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment Emergent Adverse Events
time frame: 52 Weeks
description: Occurrence of treatment emergent adverse events
measure: Serious Adverse Events
time frame: 52 Weeks
description: Occurrence of treatment serious adverse events
measure: Investigator Global Assessment
time frame: 52 Weeks
description: Achievement of an IGA score of 'completely clear' or 'almost clear' as observed over time. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
measure: Investigator Global Assessment
time frame: 52 Weeks
description: A 2-grade improvement in IGA from Baseline as observed over time. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
measure: Investigator Global Assessment
time frame: 52 Weeks
description: Achievement of an IGA score of 'completely clear' or 'almost clear' plus a 2-grade improvement in IGA from baseline as observed at Week 12, Week 24. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
measure: Duration of Response
time frame: 52 Weeks
description: Duration of IGA Success, defined as the time from the first observation of IGA Success to the last time a subject's disease response meets the criteria for IGA Success. The duration of IGA Success for subjects who end treatment in IGA Success will be censored at the last disease assessment date.
measure: Treatment Free Interval
time frame: 52 Weeks
description: Treatment-free interval, defined among subjects who achieve a 'completely clear' IGA and stop treatment to all lesions, as the time from attainment of a score of 'clear' to re-starting study drug.
arm group label: Long-term safety of ARQ-154
arm group type: Experimental
description: Open-label, Long-term Safety of ARQ-154
intervention type: Drug
intervention name: ARQ-154
description: ARQ-154 foam 0.3% applied once daily for 52 weeks
arm group label: Long-term safety of ARQ-154
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
last name: David Berk, MD
role: Study Director
affiliation: Arcutis Biotherapeutics
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country: United States
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Dermatitis, Seborrheic
sharing ipd: No