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Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: July 6, 2007
Last updated: May 19, 2008
Last verified: May 2008

July 6, 2007
May 19, 2008
May 2007
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Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG) [ Time Frame: six weeks ]
Same as current
Complete list of historical versions of study NCT00497692 on Archive Site
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Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)
Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) for Dermacyd Femina Delicata
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 Femina Delicata.
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Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Drug: Lactoserum
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  • Phototypes: I, II, III and IV
  • Integral skin test in the region

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Use of antinflammatory or immune-suppression drugs
  • Personal history of atopy
  • History of sensibilization or irritation for topic products
  • Active cutaneous disease
  • Use of new drugs and/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.

18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Jaderson Lima Sanofi
May 2008

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