A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
NCT ID: NCT02068352
Last Updated: 2021-11-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2014-06-20
2015-02-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0.3% OPA-15406
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.
OPA-15406
OPA-15406 topical ointment
1% OPA-15406
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
OPA-15406
OPA-15406 topical ointment
Vehicle Ointment
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.
Vehicle ointment
OPA-15406 1%-matching placebo topical ointment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OPA-15406
OPA-15406 topical ointment
Vehicle ointment
OPA-15406 1%-matching placebo topical ointment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.
10 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles, California, United States
San Diego, California, United States
Denver, Colorado, United States
Orange Park, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Arlington Heights, Illinois, United States
Carmel, Indiana, United States
Ann Arbor, Michigan, United States
Verona, New Jersey, United States
Albuquerque, New Mexico, United States
Stony Brook, New York, United States
High Point, North Carolina, United States
Portland, Oregon, United States
Austin, Texas, United States
College Station, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Phillip, Australian Capital Territory, Australia
Kogarah, New South Wales, Australia
Woolloongabba, Queensland, Australia
Hectorville, South Australia, Australia
Fremantle, Western Australia, Australia
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-003899-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
271-12-205
Identifier Type: -
Identifier Source: org_study_id