PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea

ID#: NCT06013371

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: June 30, 2023

End Date: December 31, 2024

Contact Information:
Benjamin Ungar, MD
212-241-3288
Giselle Singer
212-241-3288
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.
Eligibility:

Inclusion Criteria:

- 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

- OR

- 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.

- OR

- 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.

Exclusion Criteria: 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.
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