Last reviewed · How we verify
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
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 240 |
| Start date | 2011-09 |
| Completion | 2011-12 |
Conditions
- Healthy
Interventions
- azelaic acid pre foam formulation
- Vehicle pre foam formulation
- Water
Primary outcomes
- 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
Countries
United States