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A Multi-Center, Double Blind, Vehicle Controlled, Study of Retin-A Micro 0.04% in the Treatment of Pediatric Acne Vulgaris in Children, Ages 9 to 11 Years of Age
A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.
Details
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 110 |
| Start date | 2009-02 |
| Completion | 2009-12 |
Conditions
- Acne Vulgaris
Interventions
- Retin-A Micro 0.04% facial acne treatment
- Vehicle control
Primary outcomes
- Change From Baseline in Total Non-inflammatory Lesion Count — Baseline to Week 12
Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
Countries
United States