MedTrace Logo

A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

NCT05372653 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-03-30

Study results available
· View outcomes & findings →

Summary

To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis

Conditions

  • Atopic Dermatitis (AD)

Interventions

DRUG

OPA-15406

0.3% or 1% ointment, topical, twice daily, for 52 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takehisa Matsumaru · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2022-12-29
Completion
2023-11-29

Countries

  • Japan

Study Locations

More Related Trials

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 NCT05372653 on ClinicalTrials.gov