Study of Ruxolitinib Cream in Children With Atopic Dermatitis
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Incyte Corporation
- Study ID
- NCT05034822
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 11 Years
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib cream — DRUGRuxolitinib 1.5% cream applied twice daily.
Study Details
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.
Key Dates
- Start date
- Dec 16, 2021
- Status verified
- Sep 2023
- Primary completion
- Aug 7, 2023
- Completion
- Aug 7, 2023
Study Design
- Enrollment
- 29 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ruxolitinib creamruxolitinib 1.5% cream will be applied twice daily to all areas of the skin affected by AD
Primary Outcome Measure
Number of treatment-emergent adverse events [ Time Frame: Up to approximately 61 weeks ]
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Desert Sky Dermatology | Gilbert | Arizona | 85295 | - |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | - |
| Orange County Research Center | Anaheim | California | 92801 | - |
| Skin Care Research, Llc Scr Hollywood | Hollywood | Florida | 33021 | - |
| Accel Clinical Research | Lake Mary | Florida | 32746 | - |
| San Marcus Research Clinic Inc. | Miami Lakes | Florida | 33014 | - |
| Forward Clinical Trials | Tampa | Florida | 33624 | - |
| Advanced Medical Research Pc | Sandy Springs | Georgia | 30328 | - |
| Aeroallergy Research Lab of Savannah | Savannah | Georgia | 31406 | - |
| Oakland Hills Dermatology Pc | Auburn Hills | Michigan | 48326 | - |
| Skin Cancer and Dermatology Institute | Reno | Nevada | 89509 | - |
| Forest Hills Dermatology Group | Forest Hills | New York | 11375 | - |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | - |
| Cyn3Rgy Research - Clinedge - Ppds | Gresham | Oregon | 97030 | - |
| Progressive Clinical Research | San Antonio | Texas | 78213 | - |
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