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Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00664391
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : February 10, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Breeze.

Condition or disease Intervention/treatment Phase
Hygiene Drug: Lactic acid (Dermacid) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze
Study Start Date : January 2008
Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Lactic acid (Dermacid)
Liquid soup to be applied in the external genital area, in small quantity, with abundantly rinse after use, during 21 days



Primary Outcome Measures :
  1. Adverse events and their intensity and their association with the treatment. [ Time Frame: 21 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664391


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

Responsible Party: GMA-CO/Medical Director, sanofi-aventis administrative office France
ClinicalTrials.gov Identifier: NCT00664391     History of Changes
Other Study ID Numbers: LACAC_L_03746
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Dermatologic Agents