A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients 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

NCT07173478

271-102-00043

Details and patient eligibility

About

To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).

Enrollment: 156 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have been diagnosed AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
• Participants with a history of AD for at least 3 years
• 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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156 participants in 2 patient groups

1% OPA-15406 foam

Experimental group

Treatment:

Drug: OPA-15406

Vehicle

Experimental group

Treatment:

Drug: Vehicle