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Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00793026
  Purpose

The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.


Condition Intervention Phase
Hygiene
 Drug: Dermacyd Breeze Pocket BR (Lactic Acid)
 Phase III

Drug Information available for: Lactic acid Ammonium lactate
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Absence of irritation [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Good acceptability [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Dermacyd Breeze Pocket BR (Lactic Acid)
Drug: Dermacyd Breeze Pocket BR (Lactic Acid)
Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive days

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Integral skin test in the region;
  • To use products of the same category;

Exclusion criteria:

  • Lactation or gestation;
  • Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
  • Cutaneous disease (local or spread) in the evaluation area;
  • Pathology which may cause immunity depression, such as HIV, diabetes;
  • Endocrine pathology
  • Solar exposure 15 days before evaluation;
  • Treatment until four months before the selection.
  • Allergic or atopic history to cosmetics products

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793026

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Jaderson Lima Sanofi-Aventis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: LACAC_L_04365
Study First Received: November 17, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00793026  
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on January 15, 2009



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