Actively Recruiting
A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
Led by Tulane University · Updated on 2025-12-23
10
Participants Needed
4
Research Sites
48 weeks
Total Duration
On this page
Sponsors
T
Tulane University
Lead Sponsor
A
Arcutis Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2a, open label study. As psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance and flares in patients with moderate to severe disease. The study will include correlative analysis to study gene expression profiling before and after therapy.
CONDITIONS
Official Title
A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the risks and purpose of the study and provide signed informed consent
- Be 18 years or older at the time of consent
- Willing to participate in all study evaluations and able to apply topical medication without difficulty
- Have a diagnosis of Hidradenitis Suppurativa with at least 5 typical lesions in flexural sites that recur over time
- Have active Hurley stage I disease or active Hurley stage II/III disease after an adequate trial of systemic or biologic therapy
- Be on a stable dose of concomitant therapy for at least 3 months before enrollment and throughout the study
- Females of childbearing potential must have a negative pregnancy test at baseline and use adequate contraception during the study
You will not qualify if you...
- Use of topical antibiotics, corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, or Hibiclens wash (except emollients) within 1 week before enrollment
- Increasing or changing doses of concurrent therapy within 90 days before study start or during the study
- History of major uncontrolled diseases affecting heart, endocrine, lungs, nervous system, psychiatric, liver, kidneys, blood, immune system, or other major conditions
- Any condition or lab abnormality placing participant at unacceptable risk or interfering with study data interpretation
- Pregnant or breastfeeding
- Major surgery or life-threatening illness within 2 weeks before study
- Active hepatitis B or C infection with detectable virus or known HIV positivity
- Known active cancer
- Severe systemic illness requiring IV antibiotics within 2 weeks before starting study drug
- Active substance abuse or history of substance abuse within 6 months prior to screening
- Use of any investigational drug within 4 weeks before randomization or 5 half-lives if known
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Lakeview Hospital
Covington, Louisiana, United States, 70433
Actively Recruiting
2
Lakeside Hospital
New Orleans, Louisiana, United States, 70001
Actively Recruiting
3
LCMC Multi-speciality Clinic
New Orleans, Louisiana, United States, 70112
Actively Recruiting
4
University Medical Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
Research Team
C
Carole Bitar, MD
CONTACT
E
Edward Coleman, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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