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Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.

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: NCT00783939
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : March 6, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).

Condition or disease Intervention/treatment Phase
Hygiene Drug: Lactic Acid Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
Study Start Date : September 2008
Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Drug: Lactic Acid
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)


Outcome Measures

Primary Outcome Measures :
  1. The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. [ Time Frame: From the treatment start to the end of the study ]

Eligibility Criteria

Information from the National Library of Medicine

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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:

  • Age between 10 and 20 years old;
  • Integral skin test in the region;
  • Use of cosmetic product of the same category;
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

  • Lactation or gestational risk or gestation;
  • Use of Anti-inflammatory, immunosuppression or antihistaminic 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

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): NCT00783939


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00783939     History of Changes
Other Study ID Numbers: LACAC_L_04307
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2009