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/NCT06013371</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-23-00464</org_study_id>
      <nct_id>NCT06013371</nct_id>
    </id_info>
    <brief_title>PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea</brief_title>
    <official_title>PDE4 Inhibition in the Treatment of Seborrheic Dermatitis and Papulopustular Rosacea With PF-07038124</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a double-blind, vehicle-controlled clinical trial. The study will take place at&#xD;
        Icahn School of Medicine at Mount Sinai. The study will include 33-39 adult subjects with&#xD;
        moderate-to-severe-Seborrheic dermatitis (SD) as well as 33-39 adult subjects with&#xD;
        moderate-to-severe papulopustular rosacea (PPR). Subjects will be randomized 2:1 to receive&#xD;
        study drug or placebo.&#xD;
  &#xD;
        Enrolled subjects will apply topical PF-07038124 0.02% ointment once daily for 8 weeks. They&#xD;
        will return for visits at weeks 4, 8, and 12 following study treatment initiation for repeat&#xD;
        clinical assessments, medication reviews, tape-strip, blood and urine sample collections, and&#xD;
        monitoring for adverse events.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After providing consent, all subjects will be assessed for study eligibility, which includes&#xD;
        a review of the subjects past and current medical conditions, familial medical history and&#xD;
        detailed review of past and current medications. Subjects will also undergo a review of past&#xD;
        topical treatments/therapies for SD or PPR, and clinical assessments (SD: clinical SD score,&#xD;
        IGA, Peak Pruritus Numerical Rating Scale [PP-NRS]; PPR: inflammatory lesion count, IGA,&#xD;
        PP-NRS).&#xD;
  &#xD;
        Subjects who meet inclusion criteria for eligibility may continue with the Baseline Visit&#xD;
        (Week 0) or can be scheduled to return for the Baseline Visit within 28 days of the Screening&#xD;
        Visit.&#xD;
  &#xD;
        At Baseline/Week 0, subjects will undergo clinical assessments (SD: clinical SD Severity&#xD;
        Score, IGA, PP-NRS; PPR: inflammatory lesion count, IGA, PP-NRS), review of concomitant&#xD;
        medications, standardized clinical photography, and a Dermatology Life Quality index (DLQI)&#xD;
        questionnaire. Subsequent clinical assessments including standardized clinical photography,&#xD;
        and questionnaire completion will be performed at follow up visits at Week 4, Week 8, and&#xD;
        Week 12. Skin tape-strip samples will be collected for mechanistic studies (described below)&#xD;
        at baseline (lesional and non-lesional facial skin), Week 4 (lesional facial skin), Week 8&#xD;
        (lesional facial skin), and Week 12 (lesional facial skin). Additional blood samples will be&#xD;
        collected and stored at baseline and at Week 8 (or early termination, whichever is first) for&#xD;
        potential future mechanistic analyses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>
      <intervention_model_description>Subjects will be randomized 2:1 to either drug or placebo</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>Treatment will be double-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Subjects reaching Investigator's Global Assessment (IGA) success - Seborrheic dermatitis (SD)</measure>
      <time_frame>Baseline and Week 8</time_frame>
      <description>IGA success defined as: clear (0) or almost clear (1) and a reduction from baseline of ≥2 points score of 0 or 1 at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.&#xD;
  Clear (0) - Complete clear, no signs of SD&#xD;
  Almost Clear (1) - Only slight pink color or trace amounts of scaling&#xD;
  Mild (2) - Pink to red color, or slight&#xD;
  Moderate (3) - Distinct redness or clearly visible scaling&#xD;
  Severe (4) - Severe score in erythema or scaling</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent change in lesion count Papulopustular Rosacea (PPR)</measure>
      <time_frame>Baseline and Week 8</time_frame>
      <description>Percent change from baseline in inflammation (papule/pustule) lesion count at 8 weeks</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in SD severity score at 8 weeks</measure>
      <time_frame>Baseline and 8 weeks</time_frame>
      <description>Change from baseline in each component and overall SD score (composed of erythema, scaling, and pruritus components) at 8 weeks. Each component scored 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). Total score from 0-12. Higher score indicates more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with treatment success via IGA in PPR</measure>
      <time_frame>Baseline and 8 weeks</time_frame>
      <description>IGA success is defined as clear (0) or almost clear (1),and a reduction from baseline of ≥2 points score of 0 or 1 at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.&#xD;
  Clear (0) - No inflammatory lesions present, no erythema&#xD;
  Almost Clear (1) - Very few, small papules/pustules, very mild erythema present&#xD;
  Mild (2) - Few small or large papules/pustules, moderate erythema&#xD;
  Moderate (3) - Several small or large papules/pustules, moderate erythema&#xD;
  Severe (4) - Numerous small and/or large papules/pustules, severe erythema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Clinical Erythema - PPR</measure>
      <time_frame>Baseline and 8 weeks</time_frame>
      <description>Change from baseline in clinical erythema assessment at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.&#xD;
  Clear (0) -Clear skin with no signs of erythema&#xD;
  Almost Clear (1) - Almost clear; slight redness&#xD;
  Mild (2) - Mild erythema; definite redness&#xD;
  Moderate (3) - Moderate erythema; marked redness&#xD;
  Severe (4) - Severe erythema; fiery redness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Patient assessment of erythema - PPR</measure>
      <time_frame>Baseline and 8 weeks</time_frame>
      <description>Change from baseline in patient severity assessment of erythema at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.&#xD;
  Clear (0) - Clear of unwanted redness&#xD;
  Almost Clear (1) - Nearly clear of unwanted redness&#xD;
  Mild (2) - Somewhat more redness than I prefer&#xD;
  Moderate (3) - More redness than I prefer&#xD;
  Severe (4 - Completely unacceptable redness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Lesion count - PPR</measure>
      <time_frame>Baseline, 8 weeks, 12 weeks</time_frame>
      <description>Change from baseline and from 8 weeks in inflammatory (papule/pustule) lesion count at 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in IGA Score - SD and PPR</measure>
      <time_frame>Baseline, 4 and 8 weeks</time_frame>
      <description>Change from baseline in IGA score at 4 and 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.&#xD;
  SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD&#xD;
  PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent change in IGA Score - SD and PPR</measure>
      <time_frame>Baseline, 4 and 8 weeks</time_frame>
      <description>Percent change from baseline in IGA score at 4 and 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.&#xD;
  SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD&#xD;
  PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in IGA Score - SD and PPR</measure>
      <time_frame>Baseline and Week 12</time_frame>
      <description>Change from baseline and from 8 weeks in IGA at 12 weeks (i.e., 4 weeks after treatment cessation). Full scale is scored from 0-4, higher score indicates more severe symptoms.&#xD;
  SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD&#xD;
  PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from Baseline at Week 8</measure>
      <time_frame>Baseline and Week 8</time_frame>
      <description>Change from baseline in PP-NRS at 8 weeks On a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', patient rates their itch at the worst moment during the previous 24 hours. Higher score indicates more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of related adverse events</measure>
      <time_frame>12 weeks</time_frame>
      <description>Number of adverse events reported throughout the study that are deemed related to study drug.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of adverse events</measure>
      <time_frame>12 weeks</time_frame>
      <description>The frequency at which adverse events that are deemed related to study drug are reported throughout the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity of Adverse Events</measure>
      <time_frame>12 weeks</time_frame>
      <description>Severity will be measured as a category (mild, Moderate, severe) according to CTCAE 5.0.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Seborrheic Dermatitis</condition>
    <condition>Papulopustular Rosacea</condition>
    <arm_group>
      <arm_group_label>PF-07038124</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PF-07038124 0.02% ointment once daily for 8 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo Ointment</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PF-07038124</intervention_name>
      <description>topical PDE4 inhibitor</description>
      <arm_group_label>PF-07038124</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Ointment</intervention_name>
      <description>matching placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subjects ≥ 18 years of age at the time of signing the informed consent&#xD;
               document.&#xD;
  &#xD;
            -  Subject is able to understand and voluntarily sign an informed consent document prior&#xD;
               to participation in any study assessments or procedures.&#xD;
  &#xD;
            -  Subject is able to adhere to the study visit schedule and other protocol requirements.&#xD;
  &#xD;
            -  Diagnosis of SD and baseline IGA ≥ 3 with facial involvement&#xD;
  &#xD;
            -  OR&#xD;
  &#xD;
            -  Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12&#xD;
  &#xD;
            -  Subject agrees to discontinue all treatments for SD and PPR from screening through&#xD;
               study completion aside from the study drug&#xD;
  &#xD;
            -  Subject is judged to be in otherwise good overall health as judged by the&#xD;
               investigator, based on medical history, physical examination, and laboratory testing.&#xD;
               (NOTE: The definition of good health means a subject does not have uncontrolled&#xD;
               significant co-morbid conditions).&#xD;
  &#xD;
            -  Females of childbearing potential (FCBP) must have a negative pregnancy test at&#xD;
               Screening and Baseline. While on the study drug and for at least 90 days after the&#xD;
               last application of the study drug, male and female participants must be willing to&#xD;
               take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP&#xD;
               who engage in activity in which conception is possible must use one of the approved&#xD;
               contraceptive options described below:&#xD;
  &#xD;
                 -  Option 1: Any one of the following highly effective contraceptive methods:&#xD;
                    hormonal contraception (oral, injection, implant, transdermal patch, vaginal&#xD;
                    ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.&#xD;
  &#xD;
                 -  OR&#xD;
  &#xD;
                 -  Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of&#xD;
                    natural [animal] membrane [for example, polyurethane]); PLUS one additional&#xD;
                    barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide;&#xD;
                    or (c) contraceptive sponge with spermicide.&#xD;
  &#xD;
          The female subject's chosen form of contraception must be effective by the time the female&#xD;
          subject is enrolled into the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          The presence of any of the following will exclude a subject from enrollment:&#xD;
  &#xD;
            -  Subjects with other skin diseases that would interfere with the study assessment in&#xD;
               the opinion of the investigator.&#xD;
  &#xD;
            -  Active bacterial, fungal, or viral skin infection within 2 weeks from study&#xD;
               initiation.&#xD;
  &#xD;
            -  Subject has clinically significant (as determined by the investigator) renal, hepatic,&#xD;
               hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological,&#xD;
               psychiatric, immunologic, or other major uncontrolled diseases (e.g., malignancy, TB,&#xD;
               thromboembolic events) that will affect the health of the subject during the study, or&#xD;
               interfere with the interpretation of study results.&#xD;
  &#xD;
            -  Subject has previously received treatment with oral or topical PDE4 inhibitors.&#xD;
  &#xD;
            -  Current other topical treatments (e.g., topical corticosteroids, topical calcineurin&#xD;
               inhibitors, topical JAK inhibitors, topical metronidazole, topical minocycline,&#xD;
               topical ivermectin, topical azelaic acid, topical brimonidine, topical oxymetazalone,&#xD;
               topical antihistamines, topical antibacterials) within 2 weeks of baseline.&#xD;
  &#xD;
            -  Use of systemic non-biologic immunosuppressive medications, including, but not limited&#xD;
               to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil,&#xD;
               azathioprine, methotrexate, tacrolimus, oral JAK inhibitors within 4 weeks of study&#xD;
               initiation.&#xD;
  &#xD;
            -  Use of systemic biologic immunosuppressive medications, including, but not limited to&#xD;
               inhibitors of IL-17, IL-12/23, or IL-23, TNF inhibitors, dupilumab, and abatacept&#xD;
               within 12 weeks of baseline.&#xD;
  &#xD;
            -  History of adverse systemic or allergic reactions to any component of the study drug.&#xD;
  &#xD;
            -  Current participation in any other study with a biologic investigational medication&#xD;
               within 6 months of baseline, or non-biologic investigational medication within 12&#xD;
               weeks of baseline.&#xD;
  &#xD;
            -  Subject who is pregnant or breast feeding.&#xD;
  &#xD;
            -  SD or PPR Baseline IGA &lt; 3; PPR inflammatory lesion count &lt;12; SD with no facial&#xD;
               involvement.&#xD;
  &#xD;
            -  Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV&#xD;
               serology at the time of screening for subjects determined by the investigators to be&#xD;
               at high-risk for this disease.&#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>Benjamin Ungar, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Benjamin Ungar, MD</last_name>
      <phone>212-241-3288</phone>
      <email>Benjamin.Ungar@mountsinai.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Giselle Singer</last_name>
      <phone>212-241-3288</phone>
      <email>giselle.singer@mssm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Benjamin Ungar</last_name>
        <phone>212-241-3288</phone>
        <email>Benjamin.Ungar@mountsinai.org</email>
      </contact>
      <contact_backup>
        <last_name>Giselle Singer</last_name>
        <phone>212-241-3288</phone>
        <email>giselle.singer@mssm.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Benjamin Ungar</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Benjamin Ungar</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Rosacea</mesh_term>
      <mesh_term>Dermatitis, Seborrheic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will be analyzed as aggregated data</ipd_description>
    </patient_data>
    <!-- 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/NCT06013371
  org study id: STUDY-23-00464
  nct id: NCT06013371
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study is a double-blind, vehicle-controlled clinical trial. The study will take place at
        Icahn School of Medicine at Mount Sinai. The study will include 33-39 adult subjects with
        moderate-to-severe-Seborrheic dermatitis (SD) as well as 33-39 adult subjects with
        moderate-to-severe papulopustular rosacea (PPR). Subjects will be randomized 2:1 to receive
        study drug or placebo.
  
        Enrolled subjects will apply topical PF-07038124 0.02% ointment once daily for 8 weeks. They
        will return for visits at weeks 4, 8, and 12 following study treatment initiation for repeat
        clinical assessments, medication reviews, tape-strip, blood and urine sample collections, and
        monitoring for adverse events.
  After providing consent, all subjects will be assessed for study eligibility, which includes
        a review of the subjects past and current medical conditions, familial medical history and
        detailed review of past and current medications. Subjects will also undergo a review of past
        topical treatments/therapies for SD or PPR, and clinical assessments (SD: clinical SD score,
        IGA, Peak Pruritus Numerical Rating Scale [PP-NRS]; PPR: inflammatory lesion count, IGA,
        PP-NRS).
  
        Subjects who meet inclusion criteria for eligibility may continue with the Baseline Visit
        (Week 0) or can be scheduled to return for the Baseline Visit within 28 days of the Screening
        Visit.
  
        At Baseline/Week 0, subjects will undergo clinical assessments (SD: clinical SD Severity
        Score, IGA, PP-NRS; PPR: inflammatory lesion count, IGA, PP-NRS), review of concomitant
        medications, standardized clinical photography, and a Dermatology Life Quality index (DLQI)
        questionnaire. Subsequent clinical assessments including standardized clinical photography,
        and questionnaire completion will be performed at follow up visits at Week 4, Week 8, and
        Week 12. Skin tape-strip samples will be collected for mechanistic studies (described below)
        at baseline (lesional and non-lesional facial skin), Week 4 (lesional facial skin), Week 8
        (lesional facial skin), and Week 12 (lesional facial skin). Additional blood samples will be
        collected and stored at baseline and at Week 8 (or early termination, whichever is first) for
        potential future mechanistic analyses.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Subjects will be randomized 2:1 to either drug or placebo
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: Treatment will be double-blind
  measure: Number of Subjects reaching Investigator's Global Assessment (IGA) success - Seborrheic dermatitis (SD)
  time frame: Baseline and Week 8
  description: IGA success defined as: clear (0) or almost clear (1) and a reduction from baseline of ≥2 points score of 0 or 1 at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.
  Clear (0) - Complete clear, no signs of SD
  Almost Clear (1) - Only slight pink color or trace amounts of scaling
  Mild (2) - Pink to red color, or slight
  Moderate (3) - Distinct redness or clearly visible scaling
  Severe (4) - Severe score in erythema or scaling
  measure: Percent change in lesion count Papulopustular Rosacea (PPR)
  time frame: Baseline and Week 8
  description: Percent change from baseline in inflammation (papule/pustule) lesion count at 8 weeks
  measure: Change in SD severity score at 8 weeks
  time frame: Baseline and 8 weeks
  description: Change from baseline in each component and overall SD score (composed of erythema, scaling, and pruritus components) at 8 weeks. Each component scored 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). Total score from 0-12. Higher score indicates more severe symptoms.
  measure: Number of patients with treatment success via IGA in PPR
  time frame: Baseline and 8 weeks
  description: IGA success is defined as clear (0) or almost clear (1),and a reduction from baseline of ≥2 points score of 0 or 1 at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.
  Clear (0) - No inflammatory lesions present, no erythema
  Almost Clear (1) - Very few, small papules/pustules, very mild erythema present
  Mild (2) - Few small or large papules/pustules, moderate erythema
  Moderate (3) - Several small or large papules/pustules, moderate erythema
  Severe (4) - Numerous small and/or large papules/pustules, severe erythema
  measure: Change in Clinical Erythema - PPR
  time frame: Baseline and 8 weeks
  description: Change from baseline in clinical erythema assessment at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.
  Clear (0) -Clear skin with no signs of erythema
  Almost Clear (1) - Almost clear; slight redness
  Mild (2) - Mild erythema; definite redness
  Moderate (3) - Moderate erythema; marked redness
  Severe (4) - Severe erythema; fiery redness
  measure: Change in Patient assessment of erythema - PPR
  time frame: Baseline and 8 weeks
  description: Change from baseline in patient severity assessment of erythema at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.
  Clear (0) - Clear of unwanted redness
  Almost Clear (1) - Nearly clear of unwanted redness
  Mild (2) - Somewhat more redness than I prefer
  Moderate (3) - More redness than I prefer
  Severe (4 - Completely unacceptable redness
  measure: Change in Lesion count - PPR
  time frame: Baseline, 8 weeks, 12 weeks
  description: Change from baseline and from 8 weeks in inflammatory (papule/pustule) lesion count at 12 weeks
  measure: Change in IGA Score - SD and PPR
  time frame: Baseline, 4 and 8 weeks
  description: Change from baseline in IGA score at 4 and 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.
  SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD
  PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema
  measure: Percent change in IGA Score - SD and PPR
  time frame: Baseline, 4 and 8 weeks
  description: Percent change from baseline in IGA score at 4 and 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.
  SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD
  PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema
  measure: Change in IGA Score - SD and PPR
  time frame: Baseline and Week 12
  description: Change from baseline and from 8 weeks in IGA at 12 weeks (i.e., 4 weeks after treatment cessation). Full scale is scored from 0-4, higher score indicates more severe symptoms.
  SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD
  PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema
  measure: Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from Baseline at Week 8
  time frame: Baseline and Week 8
  description: Change from baseline in PP-NRS at 8 weeks On a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', patient rates their itch at the worst moment during the previous 24 hours. Higher score indicates more severe symptoms.
  measure: Number of related adverse events
  time frame: 12 weeks
  description: Number of adverse events reported throughout the study that are deemed related to study drug.
  measure: Frequency of adverse events
  time frame: 12 weeks
  description: The frequency at which adverse events that are deemed related to study drug are reported throughout the study.
  measure: Severity of Adverse Events
  time frame: 12 weeks
  description: Severity will be measured as a category (mild, Moderate, severe) according to CTCAE 5.0.
  arm group label: PF-07038124
  arm group type: Experimental
  description: PF-07038124 0.02% ointment once daily for 8 weeks
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo Ointment
  intervention type: Drug
  intervention name: PF-07038124
  description: topical PDE4 inhibitor
  arm group label: PF-07038124
  intervention type: Drug
  intervention name: Placebo Ointment
  description: matching placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Benjamin Ungar, MD
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai
  last name: Benjamin Ungar, MD
  phone: 212-241-3288
  email: Benjamin.Ungar@mountsinai.org
  last name: Giselle Singer
  phone: 212-241-3288
  email: giselle.singer@mssm.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Benjamin Ungar
  investigator title: Assistant Professor
  mesh term: Dermatitis
  mesh term: Rosacea
  mesh term: Dermatitis, Seborrheic
  sharing ipd: No
  ipd description: Data will be analyzed as aggregated data