Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower
This study has been completed.
Information provided by:
First received: April 18, 2008
Last updated: January 7, 2009
Last verified: January 2009
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Adverse events and their intensity and their association with the treatment. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2007|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Lactic acid in small quantity during 21 days.
Drug: Lactic acid (Dermacid)
Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.
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