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Trial record 10 of 40 for:    Citrus reticulata

Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility

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: NCT00786097
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE November 4, 2008
First Posted Date  ICMJE November 5, 2008
Last Update Posted Date August 25, 2009
Study Start Date  ICMJE July 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2008)
The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: Throughout the study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00786097 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_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility
Official Title  ICMJE Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix
Brief Summary The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Tangerine Mix.None.
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: Dermacyd PH_DETINLYN (Lactic Acid)
Study Arms  ICMJE Experimental: 1
Dermacyd PH_DETINLYN (Lactic Acid)
Intervention: Drug: Dermacyd PH_DETINLYN (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: November 4, 2008)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Phototype Skin I,II, III e IV
  • Integral skin test in the region;
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion inclusion:

  • Lactation or gestation
  • Use of Antiinflammatory and/or immunossupression drugs
  • Personnel history of atopy;
  • History of sensitivity or irritation for topic products;
  • Active cutaneous disease;
  • Use of new drugs or cosmetics during the study

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 18 Years to 60 Years   (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 NCT00786097
Other Study ID Numbers  ICMJE LACAC_L_04305
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 August 2009

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