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

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Primary and study completion dates changed from estimate of Sep 2026 to Sep 28, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised at 4 of 4 sites
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Sep 25, 2025
    • Site details revised at 4 of 4 sites
    v3
  3. Minor Study title shortened, about 2 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07077902
Lead Sponsor Tulane University
Collaborators: Arcutis Biotherapeutics, Inc.
Conditions
(from sponsor)
Hidradenitis Suppurativa
Related terms Hidradenitis Suppurativa
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov