A Phase 4, Open Label Study to Assess Descriptive Classification of Pruritus Over Time With Roflumilast 0.15% Cream in Patients With Atopic Dermatitis
Integrative Skin Science and Research
Summary
This study is being done to obtain descriptive classifications of pruritus using a patient directed survey system and assess change in pruritus over time in patients with Atopic Dermatitis over 4 weeks with use of topical Roflumilast cream 0.15% QD.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subjects aged 12 years or older 2. Participants and/or legal guardians are legally competent to sign and give informed consent. 3. Clinically confirmed diagnosis of active mild to moderate AD according to Hanifin and Rajka criteria (1980). 4. History of AD for at least 6 months as determined by the Investigator using information from the subject's medical chart, from the subject's physician, or through subject/caregiver interview. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening 5. At least 3 months of c…
Interventions
- DrugRoflumilast Cream 0.15%
topically applied to the affected areas once daily
Location
- Integrative Skin Science and ResearchSacramento, California