At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 32 enrolled

Drug / intervention

0.3% OPA-15406 Ointment +3 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/NCT02334787

NCT02334787Phase 1Completed

Compare CT.gov

A Single-center, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Assess the Safety and Pharmacokinetics of OPA-15406 Ointment in Healthy Adult Male Subjects (Phase 1 Trial)

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jan 8, 2015·Updated Oct 3, 2016

In Brief

A Phase 1 clinical trial evaluating 0.3% OPA-15406 Ointment, 1% OPA-15406 Ointment, and 2 other interventions for Atopic Dermatitis. Completed, enrolled 32 participants across 1 site.

Detailed Summary

To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or 3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAtopic Dermatitis

CountriesJapan

Collaborators--

Timeline

Phase 1CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartJan 2015

First PostedJan 2015

Primary CompletionFeb 2015

TodayJul 2026

First PostedJan 8, 2015

Enrollment StartJan 1, 2015

Primary CompletionFeb 1, 2015

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 11.5 years ago

Interventions

0.3% OPA-15406 Ointmentdrug

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 0.3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.

1% OPA-15406 Ointmentdrug

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose

3% OPA-15406 Ointmentdrug

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.

Placebo Ointmentdrug

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration periodriod, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.