NCT07077902 A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
| NCT ID | NCT07077902 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tulane University |
| Condition | Hidradenitis Suppurativa |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2025-09-25 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Carole Bitar, MD
PRINCIPAL INVESTIGATOR
Tulane University
Frequently Asked Questions
Who can join the NCT07077902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Hidradenitis Suppurativa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07077902 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07077902 currently recruiting?
Yes, NCT07077902 is actively recruiting participants. Contact the research team at cbitar@tulane.edu for enrollment information.
Where is the NCT07077902 trial being conducted?
This trial is being conducted at Covington, United States, New Orleans, United States, New Orleans, United States, New Orleans, United States.
Who is sponsoring the NCT07077902 clinical trial?
NCT07077902 is sponsored by Tulane University. The principal investigator is Carole Bitar, MD at Tulane University. The trial plans to enroll 10 participants.