A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppura… (NCT07077902) | Clinical Trial Compass
RecruitingPhase 2
A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
United States10 participantsStarted 2025-09-25
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent.
* Must be 18 years at time of signing informed consent form.
* Willing to participate in all required evaluations and procedures in the study including the ability to apply topical medication without difficulty.
* Patients must have a diagnosis of HS based upon the clinical criteria of a history of more than or equal 5 typical lesions (erythematous papules, nodules, or abscesses) in flexural sites with a recurring nature over time.
* Patients must be candidate for topical therapy defined by active Hurley stage I or Hurley stage II/III with active disease after an adequate trial of systemic antibiotics/hormonal/immunomodulatory or biologic therapy.
* Patient is required to be on stable dose of concomitant therapy for at least 3 months before enrollment and throughout the study period.
* Females of childbearing potential must have a negative urine pregnancy test at baseline visit and be on adequate contraception throughout the study time.
Exclusion Criteria:
* Concomitant use of topical antibiotics, topical corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, Hibiclens wash (except for emollients) within 1 week of enrollment.
* Increasing or changing dosing for concurrent therapy agents within 90 days before study day 0 and during the study period.
* History of any clinically significant (as determined by the investigator) cardiac,…
What they're measuring
1
Measure the change in gene expression profile at week 16 of using topical roflumilast vs baseline