CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 364 enrolled
Drug / intervention
1% OPA-15406 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03908970
NCT03908970Phase 3Completed
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A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Ointment to the Vehicle in Adult Patients With Atopic Dermatitis (Phase 3 Trial)

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Apr 9, 2019·Updated Jan 25, 2021

In Brief

A Phase 3 clinical trial evaluating 1% OPA-15406 and Placebos for Atopic Dermatitis. Completed, enrolled 364 participants across 1 site.

Detailed Summary

To demonstrate the superiority of IMP (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 adult patients with AD.

Study Details

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

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 9, 2019
Enrollment StartMar 25, 2019
Primary CompletionDec 28, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.2 years ago

Interventions

1% OPA-15406drug

Twice daily

Placebosdrug

Twice daily