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

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ClinicalTrials.gov Identifier: NCT00663273
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : January 8, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hygiene Drug: Lactic acid (Dermacid) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 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 Tina Gel Sweet Flower
Study Start Date : December 2007
Actual Primary Completion Date : January 2008

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Arms and Interventions
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Arm Intervention/treatment
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.


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

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 20 Years   (Child, 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.

Contacts and Locations
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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): NCT00663273


Locations
Brazil
Sanofi-aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
More Information
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Responsible Party: GMA-CO/Medical Director, sanofi-aventis administrative office France
ClinicalTrials.gov Identifier: NCT00663273     History of Changes
Other Study ID Numbers: LACAC_L_03732
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: January 8, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Dermatologic Agents