Dermatological Evaluation of Topic Compatibility - Dermacyd Breeze

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00668577
First received: April 23, 2008
Last updated: February 9, 2009
Last verified: February 2009

April 23, 2008
February 9, 2009
December 2007
February 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 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00668577 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dermatological Evaluation of Topic Compatibility - Dermacyd Breeze
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze.

The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Pocket BR.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Healthy
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
February 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:

  • 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.

Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00668577
LACAC_L_03747
No
GMA-CO/Medical Director, sanofi-aventis administrative office France
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
Sanofi
February 2009

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