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

NCT07077902 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2020-527
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Measure the change in gene expression profile at week 16 of using topical roflumilast vs baseline

  The investigators will perform gene expression profiling (GEP) using RNA sequencing on tape strips collected before and after treatment with topical roflumilast. Sixteen tape strips from lesional skin will be performed before treatment with topical roflumilast and after 4 months of treatment for gene expression profiling.

  Baseline, 16 weeks

Secondary Outcomes (3)

• Measure the overall response rate of topical roflumilast when applied to the skin of HS patients.

  Baseline, 4 months

• Measure the change in quality of life for HS patients applying topical roflumilast to their skin

  Baseline, 1 month, 4 months

• Measure the change in numerical pain score for HS patients applying topical roflumilast to their skin

  Baseline, 1 month, 4 months

Study Arms (1)

HS patients arm

EXPERIMENTAL

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.

Drug: Topical roflumilast 0.3% foam

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

HS patients arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tulane University: lead
• Arcutis Biotherapeutics, Inc.: collaborator

Study Sites (4)

Lakeview Hospital

Covington, Louisiana, 70433, United States

RECRUITING

Lakeside Hospital

New Orleans, Louisiana, 70001, United States

RECRUITING

LCMC Multi-speciality Clinic

New Orleans, Louisiana, 70112, United States

RECRUITING

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Carole Bitar, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole Bitar, MD

CONTACT

504-988-5114; cbitar@tulane.edu

Edward Coleman, MS

CONTACT

504-988-5135; ecoleman@tulane.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)