NCT07077902

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

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

With limited topical treatment options available for mild HS and for flare control, the investigators hypothesize that topical roflumilast, a phosphodiesterase-4 inhibitor (PDE4) inhibitor, is a safe and efficacious monotherapy or add-on therapy in HS patients. The study will investigate the efficacy, safety, and toxicity of topical roflumilast 0.3% foam applied to affected areas once a day as monotherapy in Hurley stage I HS patients and as add-on therapy with daily application for Hurley stage II and III HS patients on 4 months of stable treatment regimen via changes in gene expression compared to pre-treatment using Ribonucleic acid (RNA) derived from tape strip collection.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Topical roflumilast 0.3% foam	Topical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis

Timeline

• Start date: 2025-09-25
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-07-22
• Last updated: 2025-12-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study