A Study to Evaluate the Effectiveness and Safety of a Topical Ointment to Treat Subjects With Atopic Dermatitis

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in subjects with atopic dermatitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

Inclusion Criteria:

• Subjects 10-70 years of age

• Diagnosis of atopic dermatitis (AD)

• History of AD for at least 3 years

• AD affecting greater than or equal to 5% and less than or equal to 40% of total Body Surface Area (BSA) at Baseline

• Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)

Exclusion Criteria:

• Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.

• Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment areas(s) that may have an impact on the study assessments.