Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis

Otsuka

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: 0.3% OPA-15406 ointment; Drug: 1% OPA-15406 ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03961529

271-102-00006

Details and patient eligibility

About

To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.

Enrollment: 366 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: At least 2 years (at time of obtaining informed consent)
• Diagnosis of AD based on the Japanese Dermatological Association's criteria
• Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 2 patient groups

0.3% OPA-15406 ointment

Experimental group

Description:

Twice daily

Treatment:

Drug: 0.3% OPA-15406 ointment

1% OPA-15406 ointment

Experimental group

Description:

Twice daily

Treatment:

Drug: 1% OPA-15406 ointment