21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation
NCT ID: NCT01430312
Last Updated: 2020-04-01
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
40 participants
INTERVENTIONAL
2011-09-30
2011-12-31
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
BASIC_SCIENCE
DOUBLE
Study Groups
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Verum
Topical application of verum (azelaic acid pre-foam formulation) on the skin
azelaic acid pre-foam formulation
Vehicle
Topical application of vehicle formulation (same as verum but without active drug substance) on the skin
Vehicle pre-foam formulation
Negative control
Topical application of distilled water (negative control) on the skin
Water
Positive control
Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin
Sodium lauryl sulfate
Interventions
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azelaic acid pre-foam formulation
Vehicle pre-foam formulation
Water
Sodium lauryl sulfate
Eligibility Criteria
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Inclusion Criteria
* male ore female subjects
* aged 18 - 65 years
* ability to understand and fulfill the study requirements
Exclusion Criteria
* pregnancy or lactation
* not willing to comply with study requirements
18 Years
65 Years
ALL
Yes
Sponsors
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Bayer
INDUSTRY
LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Robert I. Cooper, MD
Fargo, North Dakota, United States
Countries
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Other Identifiers
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1401841
Identifier Type: OTHER
Identifier Source: secondary_id
15853
Identifier Type: -
Identifier Source: org_study_id
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