21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: azelaic acid pre-foam formulationDrug: Vehicle pre-foam formulation
- Registration Number
- NCT01430312
- Lead Sponsor
- LEO Pharma
- Brief Summary
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.
- Detailed Description
This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- healthy volunteers
- male ore female subjects
- aged 18 - 65 years
- ability to understand and fulfill the study requirements
Exclusion Criteria
- affected skin in designated test area
- pregnancy or lactation
- not willing to comply with study requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive control Sodium lauryl sulfate Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin Verum azelaic acid pre-foam formulation Topical application of verum (azelaic acid pre-foam formulation) on the skin Vehicle Vehicle pre-foam formulation Topical application of vehicle formulation (same as verum but without active drug substance) on the skin Negative control Water Topical application of distilled water (negative control) on the skin
- Primary Outcome Measures
Name Time Method irritancy rating scale 21 days skin reaction as well as superficial layer effects will be scored according to standardized scales
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Robert I. Cooper, MD
🇺🇸Fargo, North Dakota, United States