Trials / Completed
CompletedNCT03745638
Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 631 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ruxolitinib Cream | Ruxolitinib cream applied topically to the affected area as a thin film twice daily. |
| DRUG | Vehicle Cream | Matching vehicle cream applied topically to the affected area as a thin film twice daily. |
Timeline
- Start date
- 2018-12-20
- Primary completion
- 2019-12-23
- Completion
- 2020-12-01
- First posted
- 2018-11-19
- Last updated
- 2023-09-28
- Results posted
- 2021-12-17
Locations
79 sites across 7 countries: United States, Canada, France, Germany, Hungary, Italy, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03745638. Inclusion in this directory is not an endorsement.