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An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products (Retin-A Micro Gel, 0.04% Pump and Epiduo Gel) Using a Split-Face Model
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.
Details
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 162 |
| Start date | 2009-07 |
| Completion | 2009-10 |
Conditions
- Acne Vulgaris
Interventions
- Tretinoin Facial Gel
- Adapalene/Benzoyl Peroxide Facial Gel
Primary outcomes
- Facial Irritation and Cutaneous Effects — three weeks
Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.
Countries
United States