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Dermacyd Delicata Breeze - Photo Evaluation

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

April 23, 2008
February 9, 2009
January 2008
February 2008   (Final data collection date for primary outcome measure)
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type. [ Time Frame: 5 weeks ]
Same as current
Complete list of historical versions of study NCT00668486 on Archive Site
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Dermacyd Delicata Breeze - Photo Evaluation
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Breeze.
The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Breeze.
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Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Drug: Lactic acid (Dermacid)
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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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February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Phototype Skin II and III
  • Integral skin test in the region

Exclusion Criteria:

  • Lactation or gestation
  • Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
  • Diseases which can cause immunity decrease, such as HIV, diabetes
  • Use of drug photosensitizer
  • History of sensitivity or irritation for topic products
  • Active cutaneous disease which can change the study results
  • History or photodermatosis active
  • Family or personal antecedent of cutaneous photoinduced neoplasias
  • Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
  • Intense solar exposure in the study area
  • 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)
Contact information is only displayed when the study is recruiting subjects
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GMA-CO/Medical Director, sanofi-aventis administrative office France
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Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
February 2009

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