xml: <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/NCT05981118</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00099131</org_study_id>
      <nct_id>NCT05981118</nct_id>
    </id_info>
    <brief_title>Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)</brief_title>
    <official_title>Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Dermavant Sciences, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Wake Forest University Health Sciences</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</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>
        The purpose of this prospective study is to evaluate the degree of post-inflammatory&#xD;
        pigmentation alteration on legs of study subjects treated with two different psoriasis&#xD;
        treatments. Betamethasone dipropionate 0.05% cream is a high potency steroid that is commonly&#xD;
        used to alleviate the inflammation of psoriasis. Tapinarof is another medication approved for&#xD;
        psoriasis; tapinarof activates aryl hydrocarbon receptors to downregulate inflammatory&#xD;
        cytokines (such as interleukin [IL]-17) which play a large role in psoriasis. Study subjects&#xD;
        will be randomized to receive one of these medications and will be followed to monitor for&#xD;
        PIPA. Photographs will be taken to help evaluate visual changes. The Taylor Hyperpigmentation&#xD;
        scale will be used to grade the area and severity of hyperpigmentation and hypopigmentation;&#xD;
        severity of erythema, burning, peeling, and dryness will also be recorded. This will allow us&#xD;
        to understand the effects of two standard-of-care psoriasis medications to better treat&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subjects will be randomized to either of the two treatment groups (betamethasone dipropionate&#xD;
        or tapinarof) and will be treated with that medication for until clear or up to 12 weeks .&#xD;
        Photographs will be taken before and after treatment. The betamethasone dipropionate 0.05%&#xD;
        cream group will be treated with betamethasone dipropionate 0.05% cream once daily on both&#xD;
        legs until clear or up to 12 weeks. The tapinarof group will be treated with 1% tapinarof&#xD;
        cream applied once daily to both legs until clear or up to 12 weeks.&#xD;
  &#xD;
        Subjects will return every 4 weeks for evaluation. If disease recurs after clearing,&#xD;
        treatment will be re-instituted.&#xD;
  &#xD;
        Both groups will also be followed up at 1 and 4 weeks after end of treatment to monitor for&#xD;
        PIPA and any other after-treatment effects.&#xD;
  &#xD;
        Healthcare providers and patients may benefit from the information obtained during this&#xD;
        study; study subjects may directly benefit from participation as they will be treated with&#xD;
        standard treatments for psoriasis. We hope the information gathered will help healthcare&#xD;
        providers better serve patients and identify psoriasis treatment after-effects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>N/A</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms</measure>
      <time_frame>Baseline to week 1</time_frame>
      <description>Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms</measure>
      <time_frame>Week 1 to week 4</time_frame>
      <description>Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms</measure>
      <time_frame>Week 4 to week 12</time_frame>
      <description>Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>ICD10 Code L40.9 for Psoriasis</condition>
    <arm_group>
      <arm_group_label>Betamethasone dipropionate 0.05%</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The betamethasone dipropionate 0.05% cream group will be treated with betamethasone dipropionate 0.05% cream once daily on both legs until clear or up to 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tapinarof</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Betamethasone dipropionate 0.05%</intervention_name>
      <description>0.05% cream group will be treated once daily on both legs until clear or up to 12 weeks</description>
      <arm_group_label>Betamethasone dipropionate 0.05%</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tapinarof</intervention_name>
      <description>1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks</description>
      <arm_group_label>Tapinarof</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults (age 18+) with Fitzpatrick skin type 3 or higher who have been diagnosed with&#xD;
               ICD10 code L40.9 for psoriasis between [dates] at Atrium Health Wake Forest Baptist&#xD;
               Medical Center.&#xD;
  &#xD;
            2. Stable on other therapies such as biologics for at least 3 months before&#xD;
               randomization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Lack of a diagnosis of psoriasis (ICD10 code L40.9) or Fitzpatrick skin type below 3.&#xD;
  &#xD;
            2. Pigmentary changes that in the opinion of the investigator would compromise the&#xD;
               ability to assess the study outcomes.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Steven R Feldman, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Irma M Richardson, MHA</last_name>
      <phone>336-716-2903</phone>
      <email>irichard@wakehealth.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wake Forest University Health Sciences Department of Dermatology</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</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>Psoriasis</mesh_term>
      <mesh_term>Pigmentation Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Betamethasone</mesh_term>
      <mesh_term>Betamethasone Valerate</mesh_term>
      <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
      <mesh_term>Betamethasone benzoate</mesh_term>
      <mesh_term>Betamethasone sodium phosphate</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981118
  org study id: IRB00099131
  nct id: NCT05981118
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this prospective study is to evaluate the degree of post-inflammatory
        pigmentation alteration on legs of study subjects treated with two different psoriasis
        treatments. Betamethasone dipropionate 0.05% cream is a high potency steroid that is commonly
        used to alleviate the inflammation of psoriasis. Tapinarof is another medication approved for
        psoriasis; tapinarof activates aryl hydrocarbon receptors to downregulate inflammatory
        cytokines (such as interleukin [IL]-17) which play a large role in psoriasis. Study subjects
        will be randomized to receive one of these medications and will be followed to monitor for
        PIPA. Photographs will be taken to help evaluate visual changes. The Taylor Hyperpigmentation
        scale will be used to grade the area and severity of hyperpigmentation and hypopigmentation;
        severity of erythema, burning, peeling, and dryness will also be recorded. This will allow us
        to understand the effects of two standard-of-care psoriasis medications to better treat
        patients.
  Subjects will be randomized to either of the two treatment groups (betamethasone dipropionate
        or tapinarof) and will be treated with that medication for until clear or up to 12 weeks .
        Photographs will be taken before and after treatment. The betamethasone dipropionate 0.05%
        cream group will be treated with betamethasone dipropionate 0.05% cream once daily on both
        legs until clear or up to 12 weeks. The tapinarof group will be treated with 1% tapinarof
        cream applied once daily to both legs until clear or up to 12 weeks.
  
        Subjects will return every 4 weeks for evaluation. If disease recurs after clearing,
        treatment will be re-instituted.
  
        Both groups will also be followed up at 1 and 4 weeks after end of treatment to monitor for
        PIPA and any other after-treatment effects.
  
        Healthcare providers and patients may benefit from the information obtained during this
        study; study subjects may directly benefit from participation as they will be treated with
        standard treatments for psoriasis. We hope the information gathered will help healthcare
        providers better serve patients and identify psoriasis treatment after-effects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
  time frame: Baseline to week 1
  description: Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale
  measure: Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
  time frame: Week 1 to week 4
  description: Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale
  measure: Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
  time frame: Week 4 to week 12
  description: Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale
  arm group label: Betamethasone dipropionate 0.05%
  arm group type: Active Comparator
  description: The betamethasone dipropionate 0.05% cream group will be treated with betamethasone dipropionate 0.05% cream once daily on both legs until clear or up to 12 weeks.
  arm group label: Tapinarof
  arm group type: Active Comparator
  description: The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.
  intervention type: Drug
  intervention name: Betamethasone dipropionate 0.05%
  description: 0.05% cream group will be treated once daily on both legs until clear or up to 12 weeks
  arm group label: Betamethasone dipropionate 0.05%
  intervention type: Drug
  intervention name: Tapinarof
  description: 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks
  arm group label: Tapinarof
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Steven R Feldman, MD, PhD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Irma M Richardson, MHA
  phone: 336-716-2903
  email: irichard@wakehealth.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Psoriasis
  mesh term: Pigmentation Disorders
  mesh term: Betamethasone
  mesh term: Betamethasone Valerate
  mesh term: Betamethasone-17,21-dipropionate
  mesh term: Betamethasone benzoate
  mesh term: Betamethasone sodium phosphate