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
58 participants
INTERVENTIONAL
2018-03-20
2018-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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LEO 90100 foam
LEO 90100 foam (containing calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g).
Pilot part: 6 single applications of LEO 90100 foam on Day 1 (for 12 sites in total).
Pivotal part: To be decided based on the result of the pilot part
LEO 90100 foam
A foam formulation of the active comparator Dovobet® ointment
Dovobet® ointment
Pilot part: 6 single applications of Dovobet® ointment on Day 1 (for 12 sites in total).
Pivotal part: To be decided based on the result of the pilot part
Dovobet® ointment
Ointment formulation containing same active ingredients as LEO 90100 foam
Interventions
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LEO 90100 foam
A foam formulation of the active comparator Dovobet® ointment
Dovobet® ointment
Ointment formulation containing same active ingredients as LEO 90100 foam
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of any medication (systemic or topical) within 2 weeks of Day 1.
20 Years
40 Years
MALE
Yes
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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Investigational site
Fukuoka, , Japan
Countries
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Other Identifiers
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LP0053-1417
Identifier Type: -
Identifier Source: org_study_id
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