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

NCT07184645 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-09-22

No results posted yet for this study

Summary

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

Conditions

  • Atopic Dermatitis (AD)

Interventions

DRUG

OPA-15406

0.3% foam or 1% foam, topical, twice daily, for 8 weeks

DRUG

Vehicle

vehicle, topical, twice daily, for 8 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nobuhito Sanada · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07184645 on ClinicalTrials.gov