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

This study has been completed.
Information provided by:
Sanofi Identifier:
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.

Condition Intervention Phase
Drug: Lactic acid (Dermacid)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Tangerina Mix

Resource links provided by NLM:

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 ]

Enrollment: 30
Study Start Date: December 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.


Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00663325

São Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
  More Information

Responsible Party: GMA-CO/Medical Director, sanofi-aventis administrative office France Identifier: NCT00663325     History of Changes
Other Study ID Numbers: LACAC_L_03735
Study First Received: April 18, 2008
Last Updated: January 7, 2009

Additional relevant MeSH terms:
Dermatologic Agents processed this record on May 25, 2017