A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association

• Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations

• Subjects who have an 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