A Study to Evaluate the Effectiveness and Safety of a Topical Ointment to Treat Subjects With Atopic Dermatitis



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:10 - 70
Updated:4/21/2016
Start Date:June 2014
End Date:February 2015

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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

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

Atopic dermatitis is a disease mainly characterized by pruritic eczema, and patients 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 subjects with mild to moderate AD.

Inclusion Criteria:

- Subjects 10-70 years of age

- Diagnosis of atopic dermatitis (AD)

- History of AD for at least 3 years

- AD affecting greater than or equal to 5% and less than or equal to 40% of total Body
Surface Area (BSA) at Baseline

- Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3
(moderate) in the selected treatment area(s)

Exclusion Criteria:

- Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.

- Concurrent diseases/conditions and history of other diseases/conditions in the
selected treatment areas(s) that may have an impact on the study assessments.
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