Topical roflumilast 0.3% foam for 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.

This will test whether applying roflumilast 0.3% foam once daily helps people with mild hidradenitis suppurativa on its own and helps control flares or maintenance when added to treatment for those with moderate-to-severe disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Tulane University (Academic / other)
• Locations: 4 sites (Covington, Louisiana and 3 other locations)
• Trial ID: NCT07077902 on ClinicalTrials.gov

What this trial studies

This is an open-label phase 2a study of daily topical roflumilast 0.3% foam in adults with hidradenitis suppurativa. Patients with Hurley stage I disease will use the foam as monotherapy, while patients with Hurley stage II or III and active disease will apply the foam in addition to a stable systemic or other regimen. The study will track safety, tolerability, and clinical response and will perform correlative gene expression profiling using RNA from tape-strip samples taken before and after treatment. Outcomes will focus on changes in skin inflammation markers and clinical signs over the treatment period.

Who should consider this trial

Good fit: Adults (18+) with a clinical diagnosis of hidradenitis suppurativa who are Hurley stage I (for monotherapy) or Hurley stage II/III with active disease and on a stable treatment regimen for at least three months are ideal candidates.

Not a fit: People who are pregnant, unable to apply topical medication, not meeting the lesion-count diagnostic criteria, or who have recently changed systemic therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could offer an effective topical option to reduce lesions and flares while avoiding added systemic side effects.

How similar studies have performed: Topical and systemic PDE4 inhibitors have shown promise in other inflammatory skin diseases and topical roflumilast has been explored in related conditions, but its use specifically in hidradenitis suppurativa is relatively novel.

Eligibility criteria

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 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.
* Patient is required to be on stable dose of concomitant therapy for at least 3 months before enrollment and throughout the study period.
* Females of childbearing potential must have a negative urine pregnancy test at baseline visit and be on adequate contraception throughout the study time.

Exclusion Criteria:

* Concomitant use of topical antibiotics, topical corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, Hibiclens wash (except for emollients) within 1 week of enrollment.
* Increasing or changing dosing for concurrent therapy agents within 90 days before study day 0 and during the study period.
* History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Pregnant or breastfeeding.
* Prior major surgery or major life-threatening medical illness within 2 weeks.
* Active hepatitis B or C infection with detectible viral nucleic acid in the blood or known Human Immunodeficiency Virus (HIV) positivity.
* Patients with known active malignancy.
* Any severe systemic illness requiring Intravenous (IV) antibiotics within the two weeks prior to initiation of the study drug.
* Active substance abuse or a history of substance abuse within 6 months prior to screening.
* Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

Where this trial is running

Covington, Louisiana and 3 other locations

• Lakeview Hospital — Covington, Louisiana, United States (Recruiting)
• Lakeside Hospital — New Orleans, Louisiana, United States (Recruiting)
• LCMC Multi-speciality Clinic — New Orleans, Louisiana, United States (Recruiting)
• University Medical Center — New Orleans, Louisiana, United States (Recruiting)

Study contacts

• Principal investigator: Carole Bitar, MD — Tulane University
• Study coordinator: Carole Bitar, MD

Conditions Hidradenitis Suppurativa; Topical roflumilast; Inflammatory skin condition; Painful nodules and abscesses in axilla and groin