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Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00497692
First received: July 6, 2007
Last updated: May 19, 2008
Last verified: May 2008

July 6, 2007
May 19, 2008
May 2007
Not Provided
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 ClinicalTrials.gov 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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hygiene
Drug: Lactoserum
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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
30
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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.

Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00497692
LACTO_L_02948
No
Not Provided
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi
Sanofi
May 2008

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