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

NCT ID: NCT07077902

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2026-09-30

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.

Detailed Description

With limited topical treatment options available for mild HS and for flare control, the investigators hypothesize that topical roflumilast, a phosphodiesterase-4 inhibitor (PDE4) inhibitor, is a safe and efficacious monotherapy or add-on therapy in HS patients.

The study will investigate the efficacy, safety, and toxicity of topical roflumilast 0.3% foam applied to affected areas once a day as monotherapy in Hurley stage I HS patients and as add-on therapy with daily application for Hurley stage II and III HS patients on 4 months of stable treatment regimen via changes in gene expression compared to pre-treatment using Ribonucleic acid (RNA) derived from tape strip collection.

Conditions

Hidradenitis Suppurativa

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Topical roflumilast 0.3% foam

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Tulane University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carole Bitar, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

Lakeview Hospital

Covington, Louisiana, United States

Site Status: RECRUITING

Lakeside Hospital

New Orleans, Louisiana, United States

Site Status: RECRUITING

LCMC Multi-speciality Clinic

New Orleans, Louisiana, United States

Site Status: RECRUITING

University Medical Center

New Orleans, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carole Bitar, MD

Role: CONTACT

Phone: 504-988-5114

Email: cbitar@tulane.edu

Edward Coleman, MS

Role: CONTACT

Phone: 504-988-5135

Email: ecoleman@tulane.edu

Facility Contacts

Carole Bitar, MD

Role: primary

Carole Bitar, MD

Role: primary

Carole Bitar, MD

Role: primary

Carole Bitar, MD

Role: primary

Other Identifiers

2020-527

Identifier Type: -

Identifier Source: org_study_id