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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: OPA-15406

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372653

271-102-00016

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 3 months to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

OPA-15406

Experimental group

Treatment:

Drug: OPA-15406