Overview

Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

Status:
Completed

Trial end date:
2019-12-13

Target enrollment:
0

Participant gender:
All

Summary

To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Otsuka Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

- Diagnosis of AD based on the Japanese Dermatological Association's criteria

- Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of
body surface area (BSA, excluding scalp) at the screening and baseline examinations

- IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

- Subjects who have an AD or contact dermatitis flare-up defined as a rapid
intensification of AD, within 28 days prior to the baseline examination