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Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00933257
First received: July 3, 2009
Last updated: September 13, 2010
Last verified: September 2010
History of Changes

July 3, 2009
September 13, 2010
June 2009
July 2009   (final data collection date for primary outcome measure)
Measure of the photo irritation test and the photosensitivity byusing UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type. [ Time Frame: From the treatment start to the end of the study (treatment period 5 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00933257 on ClinicalTrials.gov Archive Site
Not Provided
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Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal
Study Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DESILSTY_FR.

Primary Objective:

To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd PHDESILSTYFR.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hygiene
Drug: LACTIC ACID(ND)
Treatment duration 5 weeks
Experimental: Dermacyd PH_DESILSTY_FR (Lactic Acid)
Dermacyd PH_DESILSTY_FR (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.
Intervention: Drug: LACTIC ACID(ND)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
July 2009
July 2009   (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 pregnancy
  • Use of Antiinflammatory 30 days and/or immunossupression drugs until 3 months before volunteers selection
  • Disease which can cause immunosuppresion, such as diabetes, HIV
  • Concomitant use of photosensitivity drugs
  • History of sensitivity or photosensitivity with topic products
  • Cutaneous active disease which can modify the study results
  • History or activity of photodermatosis
  • Personal or family antecedents of cutaneous neoplasia photo induced
  • Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
  • Intense exposure solar in the test region
  • Use of new drugs and/or cosmetics during the study
  • Previous participation in studies using the same product in test
  • Relevant history or confirmation of alcohol or other drugs abuse
  • Intolerance detected or suspected for some component of the sample tested
  • Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00933257
LACAC_L_04808
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi
Sanofi
September 2010

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