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To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD

NCT05667623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-08-29

No results posted yet for this study

Summary

This is a multinational (China and Korea), multicenter, randomized, double-blind, vehicle-controlled, parallel-group, comparison trial to demonstrate the superiority of 1% OPA-15406 ointment to the vehicle in adult AD subjects.

Conditions

  • Atopic Dermatitis (AD)

Interventions

DRUG

1% OPA-15406 Ointment

Twice-daily administration for 4 weeks/24 weeks.

OTHER

0% OPA-15406 Vehicle

Twice-daily administration for 4 weeks/24 weeks.

Sponsors & Collaborators

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Jianzhong Zhang, PHD · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2024-06-17
Completion
2024-11-29

Countries

  • China

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 NCT05667623 on ClinicalTrials.gov