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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: OPA-15406; Drug: Vehicle ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02068352

271-12-205

2013-003899-12 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants 10-70 years of age
• Diagnosis of 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 area(s) that may have an impact on the study assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 3 patient groups, including a placebo group

0.3% OPA-15406

Experimental group

Description:

OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.

Treatment:

Drug: OPA-15406

1% OPA-15406

Experimental group

Description:

OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.

Treatment:

Drug: OPA-15406

Vehicle Ointment

Placebo Comparator group

Description:

OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.

Treatment:

Drug: Vehicle ointment