21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers

The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.

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.

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