NCT02068352

A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis

A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).

Detailed description

AD is a disease mainly characterized by pruritic eczema, and those with the disease experience repeated exacerbations and remissions. Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in participants with mild to moderate AD.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	OPA-15406	OPA-15406 topical ointment
DRUG	Vehicle ointment	OPA-15406 1%-matching placebo topical ointment

Timeline

• Start date: 2014-06-20
• Primary completion: 2015-01-28
• Completion: 2015-02-03
• First posted: 2014-02-21
• Last updated: 2021-11-23
• Results posted: 2021-11-23

Locations

30 sites across 3 countries: United States, Australia, Poland

Regulatory

• FDA-regulated drug study