PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea

NCT06013371 | Terminated Phase 2 FDA Drug

• 1 other identifier: STUDY-23-00464
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Seborrheic Dermatitis; Papulopustular Rosacea

Outcome Measures

Primary Outcomes (2)

• Number of Subjects reaching Investigator's Global Assessment (IGA) success - Seborrheic dermatitis (SD)

  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

  Baseline and Week 8

• Percent change in lesion count Papulopustular Rosacea (PPR)

  Percent change from baseline in inflammation (papule/pustule) lesion count at 8 weeks

  Baseline and Week 8

Secondary Outcomes (12)

• Change in SD severity score at 8 weeks

  Baseline and 8 weeks

• Number of patients with treatment success via IGA in PPR

  Baseline and 8 weeks

• Change in Clinical Erythema - PPR

  Baseline and 8 weeks

• Change in Patient assessment of erythema - PPR

  Baseline and 8 weeks

• Change in Lesion count - PPR

  Baseline, 8 weeks, 12 weeks

Study Arms (2)

PF-07038124

EXPERIMENTAL

PF-07038124 0.02% ointment once daily for 8 weeks

Drug: PF-07038124

Placebo

PLACEBO COMPARATOR

Placebo Ointment

Drug: Placebo Ointment

Interventions

PF-07038124 DRUG

topical PDE4 inhibitor

PF-07038124

Placebo Ointment DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 18 years of age at the time of signing the informed consent document.
• Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
• Subject is able to adhere to the study visit schedule and other protocol requirements.
• Diagnosis of SD and baseline IGA ≥ 3 with facial involvement
• Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12
• Subject agrees to discontinue all treatments for SD and PPR from screening through study completion aside from the study drug
• Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
• Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on the study drug and for at least 90 days after the last application of the study drug, male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
• Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.
• Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
• The female subject's chosen form of contraception must be effective by the time the female subject is enrolled into the study.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subjects with other skin diseases that would interfere with the study assessment in the opinion of the investigator.
• Active bacterial, fungal, or viral skin infection within 2 weeks from study initiation.
• Subject has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g., malignancy, TB, thromboembolic events) that will affect the health of the subject during the study, or interfere with the interpretation of study results.
• Subject has previously received treatment with oral or topical PDE4 inhibitors.
• Current other topical treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical metronidazole, topical minocycline, topical ivermectin, topical azelaic acid, topical brimonidine, topical oxymetazalone, topical antihistamines, topical antibacterials) within 2 weeks of baseline.
• Use of systemic non-biologic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, oral JAK inhibitors within 4 weeks of study initiation.
• Use of systemic biologic immunosuppressive medications, including, but not limited to inhibitors of IL-17, IL-12/23, or IL-23, TNF inhibitors, dupilumab, and abatacept within 12 weeks of baseline.
• History of adverse systemic or allergic reactions to any component of the study drug.
• Current participation in any other study with a biologic investigational medication within 6 months of baseline, or non-biologic investigational medication within 12 weeks of baseline.
• Subject who is pregnant or breast feeding.
• SD or PPR Baseline IGA \< 3; PPR inflammatory lesion count \<12; SD with no facial involvement.
• Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening for subjects determined by the investigators to be at high-risk for this disease.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Pfizer: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic; Rosacea

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Officials

• Benjamin Ungar, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatment will be double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects will be randomized 2:1 to either drug or placebo

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: July 19, 2023
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)