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

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children with Atopic Dermatitis in Combination with an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants under 2 Years of Age and Children with Atopic Dermatitis (Phase 3 Trial)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250374

Enrollment

198

Registered

2025-09-19

Start date

2025-10-21

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

0.3% foam, 1% foam or vehicle, topical, twice daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association) 2) 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 3) Participants with an IGA score of 2 or 3 at the screening and baseline examinations

Exclusion criteria

Exclusion criteria: 1) Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination 2) Participants who have been treated with OPA-15406 ointment in the past

Design outcomes

Primary

Measure	Time frame
IGA success rate at Week 4	—

Contacts

Public ContactDrug Information Center

Otsuka Pharmaceutical Co., LTD.

opc_ctr@otsuka.jp+81-3-6361-7314

Outcome results

None listed

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