Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
NCT03394677 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2018-07-19
Summary
This is a multi-center, randomized, vehicle controlled, double-blind Phase 2 study in pediatric patients age 2-17 years old with mild to moderate atopic dermatitis.
Conditions
Interventions
- DRUG
-
RVT-501 0.5% ointment
Patients will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.
- DRUG
-
Vehicle ointment
Placebo comparator - ointment twice daily (BID) for 4 weeks.
Sponsors & Collaborators
-
Dermavant Sciences GmbH
lead INDUSTRY
Principal Investigators
-
James Lee, MD, PhD · Dermavant Sciences, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-25
- Primary Completion
- 2018-07-02
- Completion
- 2018-07-02
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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