A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
NCT ID: NCT01702181
Last Updated: 2014-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
92 participants
INTERVENTIONAL
2012-08-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo.
Placebo
Tacrolimus
Tacrolimus 0.1% ointment twice daily for 28 days.
Tacrolimus
0.1% concentration of tacrolimus.
OPA-15406
OPA-15406
0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days
Interventions
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OPA-15406
0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days
Tacrolimus
0.1% concentration of tacrolimus.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of atopic dermatitis (AD)
* AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10% BSA for Part 2, not including face, neck, and head
* Have had a positive but inadequate response to one or more treatment course of standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV light B.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Mobile, Alabama, United States
Hot Springs, Arizona, United States
Irvine, California, United States
Orange Park, Florida, United States
Tampa, Florida, United States
Carmel, Indiana, United States
Berlin, New Jersey, United States
High Point, North Carolina, United States
Portland, Oregon, United States
College Station, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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271-12-204
Identifier Type: -
Identifier Source: org_study_id
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