Trials / Completed
CompletedNCT03257644
A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
An Open-Label, Pilot Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with atopic dermatitis (AD).
Detailed description
Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four additional cohorts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ruxolitinib phosphate cream | Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment. |
Timeline
- Start date
- 2017-09-21
- Primary completion
- 2020-10-07
- Completion
- 2020-10-07
- First posted
- 2017-08-22
- Last updated
- 2020-11-10
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03257644. Inclusion in this directory is not an endorsement.