Recruiting
Phase 2

Roflumilast

Sponsor:

Tulane University

Code:

NCT07077902

Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Topical roflumilast 0.3% foam

Study Details

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.

Conditions

Hidradenitis Suppurativa

Study ID

NCT07077902

Start date

Sep 25, 2025

Status verified date

Dec, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Topical roflumilast 0.3% foam

Topical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis

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 and Locations

Central contacts

Carole Bitar, MD

504-988-5114cbitar@tulane.edu

Edward Coleman, MS

504-988-5135ecoleman@tulane.edu

Locations

Lakeview Hospital

Recruiting

Covington, Louisiana, United States, 70433

Principal Investigator:

Carole Bitar, MD

Lakeside Hospital

Recruiting

New Orleans, Louisiana, United States, 70001

Contacts

Carole Bitar, MD

504-988-5114cbitar@tulane.edu

Principal Investigator:

Carole Bitar, MD

LCMC Multi-speciality Clinic

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Carole Bitar, MD

504-988-5114cbitar@tulane.edu

Principal Investigator:

Carole Bitar, MD

University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Carole Bitar, MD

504-988-5114cbitar@tulane.edu

Principal Investigator:

Carole Bitar, MD

More Information

Sponsor

Tulane University

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • Topical roflumilast
  • Inflammatory skin condition
  • Painful nodules and abscesses in axilla and groin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2025-12-23.