An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Modern Research Associates, PLLC
Summary
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria:1. Participants legally competent to sign and give informed consent. 2\. Males and females ages 12 years of age and older. 3. 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. 4\. Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas and groin (excluding the scalp, palms and soles). 5\. Nail psoriasis affecting ≥3 fingernails on hands. 6. An Investigator's Global Assessment of disease severity (IGA) or (I-I…
Interventions
- DrugRoflumilast 0.3% topical cream
Roflumilast 0.3% topical cream QD
Location
- Modern Research Associates, PLLCDallas, Texas