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Safety and Acceptability of Dermacyd Gynecological Formulation
NCT00932945Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2009
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- lactic acid
01
Overview
Phase 3, open-label, single-arm trial of lactic acid, sponsored by Sanofi. Primary endpoint: Evaluation of the absence of irritation and the good acceptability at 21 days. Started Jun 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Dermacyd PH_DESILSTY_FR (Lactic Acid)
Treatment duration: 21 consecutive days
03
Who it enrols
Healthy women with no cutaneous active disease in the evaluated area, no history of allergic or atopic reactions to cosmetics, and no immunosuppressive diseases or treatments.
04
Endpoints
Primary
Evaluation of the absence of irritation and the good acceptability
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