Status:
TERMINATED
PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Pfizer
Conditions:
Seborrheic Dermatitis
Papulopustular Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-seve...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06013371
Start Date
July 19 2023
End Date
February 18 2025
Last Update
April 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029