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.
Single group
Topical roflumilast 0.3% foam
DrugTopical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis
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.
Measure the overall response rate of topical roflumilast when applied to the skin of HS patients.
The efficacy assessment will be based on overall response rate (ORR) of topical roflumilast in patients with HS at 4 months. The ORR will be measured using the change in total abscess and inflammatory nodule count (AN count) at week 16 vs number of active lesions at baseline. Change from baseline will be calculated as the week 16 value minus the baseline value.
Measure the change in quality of life for HS patients applying topical roflumilast to their skin
The investigators will assess the patients' quality of life using Dermatology Life Quality Index (DLQI) score ranging from (0-30) where 0 has no effect on quality of life and 30 has an extremely large effect on quality of life. DLQI will be measured at months 0, 1 and 4 months. The minimal clinically important difference on the DLQI score is a change of 4.
Measure the change in numerical pain score for HS patients applying topical roflumilast to their skin
The investigators will assess the skin pain response using Numerical Rating Scale (NRS30). NRS an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). NRS will be measured at months 0, 1 and 4 months. The minimal clinically meaningful important difference on the NRS score is ≥30% reduction and ≥2-point reduction in skin pain from baseline.
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Tulane University
Lead sponsor
Arcutis Biotherapeutics, Inc.
Collaborator
