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Trial record 5 of 6 for:    lactic acid | Citrus reticulata

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:
Sanofi

Tracking Information
First Submitted Date  ICMJE October 31, 2008
First Posted Date  ICMJE November 3, 2008
Last Update Posted Date March 6, 2009
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2008)
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 ]
Change History Complete list of historical versions of study NCT00783939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.
Official Title  ICMJE Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Hygiene
Intervention  ICMJE Drug: Lactic Acid
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Study Arms  ICMJE Experimental: 1
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Intervention: Drug: Lactic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2008)
31
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 10 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00783939
Other Study ID Numbers  ICMJE LACAC_L_04307
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jaderson Lima Sanofi
PRS Account Sanofi
Verification Date March 2009

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