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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Topical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis
Lakeview Hospital
Covington, Louisiana, United States
RECRUITINGLakeside Hospital
New Orleans, Louisiana, United States
RECRUITINGLCMC Multi-speciality Clinic
New Orleans, Louisiana, United States
RECRUITINGUniversity Medical Center
New Orleans, Louisiana, United States
RECRUITINGMeasure 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.
Time frame: Baseline, 16 weeks
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.
Time frame: Baseline, 4 months
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.
Time frame: Baseline, 1 month, 4 months
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.
Time frame: Baseline, 1 month, 4 months
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