Study of Ruxolitinib Cream in Children With Atopic Dermatitis
NCT05034822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2023-09-15
Summary
This is an open-label maximum use trial to evaluate ruxolitinib safety, tolerability and blood levels after its topical application twice daily to affected areas (≥ 35% BSA) in pediatric participants with atopic dermatitis (AD) and to determine if its systemic bioavailability results in any adverse events.
Conditions
Interventions
- DRUG
-
Ruxolitinib cream
Ruxolitinib 1.5% cream applied twice daily.
Sponsors & Collaborators
-
Innovaderm Research
collaborator UNKNOWN - lead INDUSTRY
Principal Investigators
-
Haq Nawaz, MD, MPH, MBA, MS · Incyte Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-16
- Primary Completion
- 2023-08-07
- Completion
- 2023-08-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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