Phase 2 Study of Topical Roflumilast 0.3% Foam for Treating Hidradenitis Suppurativa Evaluating Safety and Effectiveness as Monotherapy or Add-on Treatment Including Analysis of Gene Expression Changes

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.

A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa