CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
OPA-15406 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Diagnosis of atopic dermatitis based on Hanifin and Rajka criteria
Key exclusion· 3
  • ✕Active atopic dermatitis or contact dermatitis flare-up (sudden intensification)
  • ✕Active viral skin infection
  • ✕Current or history of malignancy

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

Search/NCT03018691
NCT03018691Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Trial to Assess the Safety and Efficacy of 0.3% and 1% OPA-15406 Ointments When Administered for 4 Weeks in Pediatric Patients With Atopic Dermatitis

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jan 12, 2017·Updated Jul 23, 2020

In Brief

A Phase 2 clinical trial evaluating OPA-15406 and Placebos for Atopic Dermatitis. Completed, enrolled 73 participants across 4 sites.

Detailed Summary

To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 12, 2017
Enrollment StartJan 1, 2017
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.5 years ago

Interventions

OPA-15406drug

Placebosdrug