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Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Safety
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00785148
  Purpose

To prove the safety of the gynaecological formulation in normal conditions of use.


Condition Intervention Phase
Hygiene
 Drug: Dermacyd PH_DETINLYN (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, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN (Lactic Acid)Sweet Flower.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. [ Time Frame: Troughout the study ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Dermacyd PH_DETINLYN (Lactic Acid)
Drug: Dermacyd PH_DETINLYN (Lactic Acid)

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Integral skin test in the region
  • Use of cosmetic product of the same category

Exclusion Criteria:

  • Lactation or gestational risk or gestation
  • Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs
  • Atopic antecedent or allergic to cosmetic product
  • Active cutaneous disease in the evaluation area
  • Diseases which cause immunology decrease, such as diabetes and HIV
  • Endocrinal pathologies
  • Intense solar exposure 15 days before the evaluation
  • Treatment until four months before the selection

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: NCT00785148

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_04298
Study First Received: November 4, 2008
Last Updated: November 4, 2008
ClinicalTrials.gov Identifier: NCT00785148  
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on January 16, 2009



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