Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
Drug: azelaic acid pre foam formulation
Drug: Vehicle pre foam formulation
|Study Design:||Intervention Model: Single Group Assignment|
|Official Title:||A Randomized, Double-blind, Vehicle Controlled Phase 1 Dermal Safety Study to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design|
- skin sensitization reaction [ Time Frame: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase) ] [ Designated as safety issue: Yes ]skin reactions will be assessed, using a standardized scoring scale
|Study Start Date:||September 2011|
|Experimental: Verum||Drug: azelaic acid pre foam formulation|
|Placebo Comparator: Vehicle||Drug: Vehicle pre foam formulation|
|Placebo Comparator: Negative control||Drug: Water|
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.