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Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668668
First Posted: April 29, 2008
Last Update Posted: January 29, 2009
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.
Information provided by:
Sanofi
April 23, 2008
April 29, 2008
January 29, 2009
December 2007
January 2008   (Final data collection date for primary outcome measure)
The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: six weeks ]
Same as current
Complete list of historical versions of study NCT00668668 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Tina Gel Sweet Flower.
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 Tina Gel Sweet Flower.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Hygiene
Drug: Lactic acid (Dermacid)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
Not Provided
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Phototype Skin I,II, III e IV
  • Integral skin test in the region

Exclusion Criteria:

  • Lactation or gestation
  • Use of Antiinflammatory and/or immunosuppression 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.

Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00668668
LACAC_L_03733
No
Not Provided
Not Provided
GMA-CO/Medical Director, sanofi-aventis administrative office France
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
Sanofi
January 2009

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