A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
Phase 1
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT01702181
- Brief Summary
The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
- Adult subjects 18-65 years of age
- Diagnosis of atopic dermatitis (AD)
- AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10% BSA for Part 2, not including face, neck, and head
- Have had a positive but inadequate response to one or more treatment course of standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV light B.
Exclusion Criteria
-Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus Tacrolimus Tacrolimus 0.1% ointment twice daily for 28 days. OPA-15406 OPA-15406 - Placebo Placebo Matching placebo.
- Primary Outcome Measures
Name Time Method Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms. 28 days Measurement of drug levels in the blood of treated patients 28 days
- Secondary Outcome Measures
Name Time Method Investigator's Global Assessment (IGA) of Disease Severity at Week 4 28 Days