A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

Otsuka

Status and phase: Not yet enrolling; Phase 3

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: Vehicle; Drug: OPA-15406

Study type: Interventional

Funder types: Industry

Identifiers

NCT07184645

271-102-00044

Details and patient eligibility

About

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

Enrollment: 198 estimated patients

Sex: All

Ages: 3 months to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
• Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations
• Participants with an IGA score of 2 or 3 at the screening and baseline examinations

Exclusion criteria

• Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination
• Participants who have been treated with OPA-15406 ointment in the past

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 2 patient groups

OPA-15406 foam

Experimental group

Treatment:

Drug: OPA-15406

Vehicle

Experimental group

Treatment:

Drug: Vehicle