Clinical trial NCT02068352: A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis, Eczema
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 121
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)]
timeFrame: Week 4
Secondary outcomes:
measure: Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis]
timeFrame: Baseline, Week 4
measure: Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis]
timeFrame: Baseline, Week 4
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: From signing of informed consent through Week 8
Other outcomes:
measure: Percentage of Participants With Success in the Overall IGA Score at Week 8 (Using Non-responder Imputation or LOCF Imputation)
timeFrame: Week 8
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score (Using MMRM Analysis)
timeFrame: Baseline, Weeks 4 and 8
measure: Change From Baseline in EASI Score (Using LOCF Analysis)
timeFrame: Baseline, Weeks 4 and 8
measure: Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus (Using MMRM Analysis)
timeFrame: Baseline, Weeks 4 and 8
measure: Change From Baseline in VAS for Pruritus (Using LOCF Analysis)
timeFrame: Baseline, Weeks 4 and 8
Locations:
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Orange Park
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Arlington Heights
country: United States
state: Illinois
city: Carmel
country: United States
state: Indiana
city: Ann Arbor
country: United States
state: Michigan
city: Verona
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Stony Brook
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Phillip
country: Australia
state: Australian Capital Territory
city: Kogarah
country: Australia
state: New South Wales
city: Woolloongabba
country: Australia
state: Queensland
city: Hectorville
country: Australia
state: South Australia
city: Fremantle
country: Australia
state: Western Australia
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
Study officials:
References: