Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01430533
- Lead Sponsor
- LEO Pharma
- Brief Summary
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
- Detailed Description
In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- healthy volunteers
- male or 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 Vehicle Vehicle pre foam formulation Topical application of vehicle formulation (same as verum but without active drug substance) on the skin Verum azelaic acid pre foam formulation Topical application of verum (azelaic acid pre foam formulation) on the skin Negative control Water Topical application of distilled water (negative control) on the skin
- Primary Outcome Measures
Name Time Method skin sensitization reaction day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase) skin reactions will be assessed, using a standardized scoring scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Robert I. Cooper, MD
🇺🇸Fargo, North Dakota, United States