CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 251 enrolled
Drug / intervention
0.3% OPA-15406 +2 moredrug
Likely dose
0.3% or 1% OPA-15406 ointment applied topically twice dailyAI-extracted
Key inclusion· 3
  • ✓Confirmed atopic dermatitis diagnosis per Japanese Dermatological Association criteria
  • ✓Atopic dermatitis involving 5–40% of body surface area (BSA, excluding scalp) at screening and baseline
  • ✓IGA (Investigator's Global Assessment) score of 2 or 3 at screening and baseline
Key exclusion· 1
  • ✕Active AD or contact dermatitis flare-up (rapid intensification) within 28 days prior to baseline examination

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

In the news

1 article

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT03911401
NCT03911401Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Apr 11, 2019·Updated Jan 25, 2021

In Brief

A Phase 3 clinical trial evaluating 0.3% OPA-15406, 1% OPA-15406, and 1 other intervention for Atopic Dermatitis. Completed, enrolled 251 participants across 1 site.

Detailed Summary

To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 11, 2019
Enrollment StartMay 7, 2019
Primary CompletionDec 13, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.2 years ago

Interventions

0.3% OPA-15406drug

Twice daily

1% OPA-15406drug

Twice daily

Placebosdrug

Twice daily