A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis (Phase 3 Trial)

JRCT ID: jRCT2031220124

Registered date:09/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 10/06/2022
• Target sample size: 41
• Study type: Interventional
• Intervention(s): 0.3% or 1% difamilast ointment, topical, twice daily

Outcome(s)

• Primary Outcome: Success rate in Investigator's Global Assessment (IGA)

Key inclusion & exclusion criteria

• Age minimum: >= 3month old
• Age maximum: < 2age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Matsumaru Takehisa
• Secondary ID(s): NCT05372653