Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00663273
First received: April 18, 2008
Last updated: January 7, 2009
Last verified: January 2009

April 18, 2008
January 7, 2009
December 2007
January 2008   (final data collection date for primary outcome measure)
Adverse events and their intensity and their association with the treatment. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00663273 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hygiene
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.
Experimental: 1
Lactic acid in small quantity during 21 days.
Intervention: Drug: Lactic acid (Dermacid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Integral skin test in the region;

Exclusion Criteria:

  • Lactation or gestational risk or gestation;
  • Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
  • Topical medication use at the region to be treated;
  • Cutaneous disease or active gynecological disease which may interfere in study results;
  • Personal history of allergic disease at the area to be treated;
  • Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Female
10 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00663273
LACAC_L_03732
No
GMA-CO/Medical Director, sanofi-aventis administrative office France
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
Sanofi
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP