Dermatological Evaluation of Topic Compatibility-Dermacyd Delicata Pocket BR

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00668460
First received: April 23, 2008
Last updated: January 28, 2009
Last verified: January 2009

April 23, 2008
January 28, 2009
November 2007
January 2008   (final data collection date for primary outcome measure)
The absence of primary and accumulated dermal irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00668460 on ClinicalTrials.gov Archive Site
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Dermatological Evaluation of Topic Compatibility-Dermacyd Delicata Pocket BR
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Delicata Pocket BR.

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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
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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.

Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00668460
LACAC_L_03744
No
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