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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.
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2011-09 |
| Completion | 2011-12 |
Conditions
- Healthy
Interventions
- azelaic acid pre-foam formulation
- Vehicle pre-foam formulation
- Water
- Sodium lauryl sulfate
Primary outcomes
- irritancy rating scale — 21 days
skin reaction as well as superficial layer effects will be scored according to standardized scales
Countries
United States