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Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00783939
First received: October 31, 2008
Last updated: March 5, 2009
Last verified: March 2009

October 31, 2008
March 5, 2009
September 2008
September 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00783939 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.
Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hygiene
Drug: Lactic Acid
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Experimental: 1
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Intervention: Drug: Lactic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
Not Provided
September 2008   (final data collection date for primary outcome measure)

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.

Female
10 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00783939
LACAC_L_04307
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi
Sanofi
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP