Loading clinical trials...

A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

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)

NCT07184645•Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

0 - 14 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

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

Locations (1)

Sumire Dermatology Clinic

Tokyo, Japan

Key Dates

Start Date

September 1, 2025

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

September 22, 2025

Enrollment

198

ESTIMATED participants

Conditions

Atopic Dermatitis (AD)

Interventions

OPA-15406

DRUG

Vehicle

DRUG

Contacts

Drug Information Center

CONTACT

+81-3-6361-7314

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

NCT07298395

Atopic Dermatitis (AD)

View study

RECRUITINGPHASE1

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

NCT07235384

Atopic Dermatitis (AD)

View study

RECRUITINGNA

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Herbal Ointment in Treating Atopic Dermatitis Topically

Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis