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Dermacyd Delicata Pocket BR - Photo Evaluation

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00668226
First received: April 23, 2008
Last updated: January 28, 2009
Last verified: January 2009

April 23, 2008
January 28, 2009
December 2007
January 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00668226 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dermacyd Delicata Pocket BR - Photo Evaluation
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Delicata Pocket BR.

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Delicata 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
25
Not Provided
January 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.

Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00668226
LACAC_L_03745
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