A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
NCT ID: NCT07184645
Last Updated: 2025-09-22
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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NOT_YET_RECRUITING
PHASE3
198 participants
INTERVENTIONAL
2025-09-30
2027-02-28
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
QUADRUPLE
Study Groups
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OPA-15406 foam
OPA-15406
0.3% foam or 1% foam, topical, twice daily, for 8 weeks
Vehicle
Vehicle
vehicle, topical, twice daily, for 8 weeks
Interventions
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OPA-15406
0.3% foam or 1% foam, topical, twice daily, for 8 weeks
Vehicle
vehicle, topical, twice daily, for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations
* Participants with an IGA score of 2 or 3 at the screening and baseline examinations
Exclusion Criteria
* Participants who have been treated with OPA-15406 ointment in the past
3 Months
14 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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Nobuhito Sanada
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
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Sumire Dermatology Clinic
Tokyo, , Japan
Countries
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Central Contacts
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Drug Information Center
Role: CONTACT
Other Identifiers
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271-102-00044
Identifier Type: -
Identifier Source: org_study_id
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