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.
Tulane University
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.
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 comp…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
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 f…
Interventions
- DrugTopical roflumilast 0.3% foam
Topical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis
Locations (4)
- Lakeview HospitalCovington, Louisiana
- Lakeside HospitalNew Orleans, Louisiana
- LCMC Multi-speciality ClinicNew Orleans, Louisiana
- University Medical CenterNew Orleans, Louisiana