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

Part of paid clinical trials in Covington, Louisiana.

Sponsor
Tulane University
Study ID
NCT07077902
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 25, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HS patients arm
    Patients must have a diagnosis of HS based upon the clinical criteria of a history of more or equal than 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.

Primary Outcome Measure

Measure the change in gene expression profile at week 16 of using topical roflumilast vs baseline [ Time Frame: Baseline, 16 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Lakeview HospitalCovingtonLouisiana70433
Carole Bitar, MD
Carole Bitar, MD (PRINCIPAL_INVESTIGATOR)
Lakeside HospitalNew OrleansLouisiana70001
Carole Bitar, MD
[email protected]
504-988-5114
Carole Bitar, MD (PRINCIPAL_INVESTIGATOR)
LCMC Multi-speciality ClinicNew OrleansLouisiana70112
Carole Bitar, MD
[email protected]
504-988-5114
Carole Bitar, MD (PRINCIPAL_INVESTIGATOR)
University Medical CenterNew OrleansLouisiana70112
Carole Bitar, MD
[email protected]
504-988-5114
Carole Bitar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Covington, LA

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Lakeview Hospital· Covington, LALakeside Hospital· New Orleans, LALCMC Multi-speciality Clinic· New Orleans, LAUniversity Medical Center· New Orleans, LA

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