Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome
NCT ID: NCT03908970
Last Updated: 2021-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
364 participants
INTERVENTIONAL
2019-03-25
2019-12-28
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
TRIPLE
Study Groups
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1% OPA-15406
Twice daily
1% OPA-15406
Twice daily
Placebo
Twice daily
Placebos
Twice daily
Interventions
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1% OPA-15406
Twice daily
Placebos
Twice daily
Eligibility Criteria
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Inclusion Criteria
* History of AD for at least 3 years
* Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
* IGA score of 2 or 3 at the screening and baseline examinations
Exclusion Criteria
15 Years
70 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Osamu Sato
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
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Kitago Hifuka Clinic
Sapporo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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271-102-00007
Identifier Type: -
Identifier Source: org_study_id
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