This is an open label trial in subjects ≥12 years of age and older with chronic plaque psoriasis and moderate to severe nail psoriasis.
Eligible participants will apply roflumilast 0.3% cream daily for 24 weeks to affected nails daily for the entire study duration and to psoriasis plaques daily until clear.
Participants legally competent to sign and give informed consent.
Males and females ages 12 years of age and older.
Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable psoriasis for the past 6 months and stable nail disease for the past 6 months.
Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas and groin (excluding the scalp, palms and soles).
Subjects who cannot discontinue medication and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table 1).
Subjects who currently have or plan to have gel or acrylic overlays on nails during the study.
Subjects who cannot discontinue nail care habits that will confound efficacy and safety assessments (e.g. buffing, filing, excessive trimming). Routine simple clipping is allowed.
Subjects who cannot discontinue any nail topcoat products (e.g. hardeners, strengtheners, nail polish) Simple nail polish will be allowed for special events and removed the next day. Subject will note in diary days this occurs and the total days may not exceed 5 study days.
Single group
Roflumilast 0.3% topical cream
DrugRoflumilast 0.3% topical cream QD
Mean Change in Nail Psoriasis Severity Index (NAPSI)
The Primary Efficacy Endpoint is NAPSI mean change from baseline at week 24
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