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.
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.
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.
Tulane University
Lead sponsor
Arcutis Biotherapeutics, Inc.
Collaborator