Actively Recruiting
An Open Label Study Evaluating Safety and Efficacy of Topical Roflumilast 0.3% Foam as Mono or Add-on Therapy for Hidradenitis Suppurativa with Gene Expression Analysis
Led by Tulane University · Updated on 2025-12-23
10
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tulane University
Lead Sponsor
A
Arcutis Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating topical roflumilast 0.3% foam as a treatment for patients with Hidradenitis Suppurativa (HS), a skin condition involving inflammatory lesions. This phase 2a, open-label study explores its safety and effectiveness both as a stand-alone treatment for mild HS and as an add-on therapy for moderate to severe cases. The study includes gene expression analysis to understand changes before and after treatment. Participants will apply topical roflumilast foam once daily to affected areas. Those with mild HS (Hurley stage I) will use it as monotherapy, while patients with moderate to severe HS (Hurley stage II or III) will add it to their stable existing treatments. The treatment period lasts 4 months, with gene expression profiling performed to assess molecular changes resulting from therapy. Participants will undergo evaluations including gene expression testing via tape strip collections at baseline and week 16. Other assessments will measure treatment response, quality of life, and pain levels at baseline, 1 month, and 4 months. Safety and tolerability will be monitored throughout the study, which runs from screening through 4 months of treatment to understand how the foam affects HS symptoms and patient well-being.
CONDITIONS
Brief 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...
- Must understand the study risks and benefits and provide signed informed consent.
- Must be 18 years or older at time of consent.
- Willing to participate in all study evaluations and able to apply topical medication.
- Have a diagnosis of Hidradenitis Suppurativa with at least 5 typical lesions in flexural sites that recur over time.
- Suitable for topical therapy with active Hurley stage I or stage II/III disease after prior systemic or biologic therapy.
- On a stable dose of current therapy for at least 3 months before and during the study.
- Female participants of childbearing potential must have a negative pregnancy test at baseline and use contraception throughout the study.
You will not qualify if you...
- Use of topical antibiotics, corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, or Hibiclens wash within 1 week before enrollment.
- Changes or increases in concurrent therapy doses within 90 days before study start or during the study.
- History of major uncontrolled diseases affecting heart, endocrine, lung, nervous system, psychiatric, liver, kidney, blood, immune system, or other serious conditions.
- Conditions or lab abnormalities that increase risk or interfere with study data.
- Pregnant or breastfeeding individuals.
- Major surgery or life-threatening illness within 2 weeks before study.
- Active hepatitis B or C infection or known HIV positivity.
- Known active cancer.
- Severe systemic illness requiring IV antibiotics within 2 weeks before treatment.
- Active or recent substance abuse within 6 months before screening.
- Use of investigational drugs within 4 weeks or 5 half-lives prior to randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants apply topical roflumilast 0.3% foam once a day to affected areas as monotherapy or add-on therapy for their Hidradenitis Suppurativa.
Baseline visit and follow-up visits during treatment
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
E
Edward Coleman, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here