Trials / Completed
CompletedNCT01702181
A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
A Multiple-Dose (0.3%, 1%, and 3% [w/w]), Randomized, Blinded, Vehicle- and Active Comparator-Controlled, Sequential Dose Cohorts, Multi-Center Trial to Assess the Safety, Pharmacokinetics, and Proof-of-Concept Efficacy of Topical OPA 15406 Ointment, Applied Twice Daily for 28 Days, in Adult Subjects With Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPA-15406 | 0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days |
| DRUG | Tacrolimus | 0.1% concentration of tacrolimus. |
| DRUG | Placebo |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2012-10-05
- Last updated
- 2014-01-17
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01702181. Inclusion in this directory is not an endorsement.