A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis
Part of paid clinical trials in Anaheim, California.
- Sponsor
- Incyte Corporation
- Study ID
- NCT03920852
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 65 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 and blood levels after its topical application twice daily to affected areas (≥ 25% BSA) in adolescent and adult participants with atopic dermatitis (AD) and to determine if its systemic bioavailability results in any adverse events.
Key Dates
- Start date
- May 30, 2019
- Status verified
- Feb 2020
- Primary completion
- Dec 26, 2019
- Completion
- Dec 26, 2019
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ruxolitinib cream
Primary Outcome Measure
Number of treatment-emergent adverse events [ Time Frame: Up to 127 days ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Orange County Research Center | Anaheim | California | 92801 | - |
| Encino Research Center | Encino | California | 91436 | - |
| RM Medical Research, INC. | Miami | Florida | 33174 | - |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | - |
| Pure Skin Dermatology Aesthetics at Accel Research | Orlando | Florida | 32819 | - |
| Metro Boston Clinical Partners | Brighton | Massachusetts | 02135 | - |
| Oakland Hills Dermatology PC | Auburn Hills | Michigan | 48326 | - |
| Clinical Research Institute of Southern Oregon - Crisor | Medford | Oregon | 97504 | - |
| Clinical Research Partners LLC | Richmond | Virginia | 23220 | - |
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