An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
NCT ID: NCT02496546
Last Updated: 2017-05-03
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
30 participants
INTERVENTIONAL
2015-07-31
2016-03-31
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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LEO 32731 cream
Topical application
LEO 32731 cream
Applied for 3 weeks
LEO 32731 cream vehicle
Topical application
LEO 32731 cream vehicle
Applied for 3 weeks
Interventions
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LEO 32731 cream
Applied for 3 weeks
LEO 32731 cream vehicle
Applied for 3 weeks
Eligibility Criteria
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Inclusion Criteria
* Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
* Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs
Exclusion Criteria
18 Years
MALE
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Locations
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Proinnovera GmbH, Center of Dermatology Excellence
Münster, , Germany
Countries
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Other Identifiers
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2014-000519-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LP0108-1082
Identifier Type: -
Identifier Source: org_study_id
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