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

A Multicenter, Randomized, Double-blind, Vehicle controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1%OPA-15406 Ointment to the Vehicle in Pediatric Patients with Atopic Dermatitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224628

Enrollment

240

Registered

2019-04-05

Start date

2019-05-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

investigational material(s) Generic name etc : OPA-15406 Ointment (0.3% ), OPA-15406 Ointment (1% ) INN of investigational material : Difamilast Therapeutic category code : 269 Other agents for epider

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Diagnosis of AD based on the Japanese Dermatological Association's criteria 2 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 3 IGA score of 2 or 3 at the screening and baseline examinations

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy IGA	—

Secondary

Measure	Time frame
efficacy EASI,VRS	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026