An Open Label Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam as a Mono or add-on Therapy in the Treatment of Hidradenitis Suppurativa With Correlative Analysis.
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.
• 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.