Overview

Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Criteria
Inclusion Criteria:

- Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

Exclusion Criteria:

- Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a
sudden intensification of atopic dermatitis.

- Subjects who have an active viral skin infection.

- Subjects with a current or history of malignancy.