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Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00785720
First received: November 4, 2008
Last updated: August 21, 2009
Last verified: August 2009
History of Changes

November 4, 2008
August 21, 2009
August 2008
September 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: Throughout the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00785720 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower

The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hygiene
Drug: Dermacyd PH_DETINBACK (Lactic Acid)
Experimental: 1
Dermacyd PH_DETINBACK (Lactic Acid)
Intervention: Drug: Dermacyd PH_DETINBACK (Lactic Acid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Phototype Skin II and III;
  • Integral skin test in the region;
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

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 of photodermatosis active;
  • Family or personal antecedent of cutaneous photoinduced neoplasias;
  • Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses 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
 
NCT00785720
LACAC_L_04303
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi
Sanofi
August 2009

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