CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
OPA-15406drug
Likely dose
OPA-15406 0.3% or 1% ointment, topical, twice dailyAI-extracted
Key inclusion· 3
  • ✓Diagnosed with atopic dermatitis according to Japanese Dermatological Association criteria
  • ✓AD affecting 5–40% of body surface area (excluding scalp) at screening and baseline
  • ✓IGA score of 2 or 3 at screening and baseline
Key exclusion· 1
  • ✕AD or contact dermatitis flare-up (rapid intensification) within 28 days prior to baseline

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05372653
NCT05372653Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-label, Uncontrolled Trial to Evaluate the Efficacy and Safety of OPA-15406 Ointment in Infants Younger Than 2 Years of Age With Atopic Dermatitis

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted May 13, 2022·Updated Mar 30, 2025

In Brief

A Phase 3 clinical trial evaluating OPA-15406 for Atopic Dermatitis (AD). Completed, enrolled 41 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis (AD)
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 13, 2022
Enrollment StartMay 23, 2022
Primary CompletionDec 29, 2022
Study CompletionNov 29, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.1 years ago

Interventions

OPA-15406drug

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