A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
Trial Parameters
Brief 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.
Eligibility Criteria
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