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.
Tulane University
10 participants
Sep 25, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria11
- 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).
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Interventions
Topical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07077902