Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

Otsuka

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03911401

271-102-00008

Details and patient eligibility

About

To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).

Enrollment: 251 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of AD based on the Japanese Dermatological Association's criteria
• Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
• 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: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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251 participants in 3 patient groups, including a placebo group

0.3% OPA-15406

Experimental group

Description:

Twice daily

Treatment:

Drug: 0.3% OPA-15406

1% OPA-15406

Experimental group

Description:

Twice daily

Treatment:

Drug: 1% OPA-15406

Placebo

Placebo Comparator group

Description:

Twice daily

Treatment:

Drug: Placebos