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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00933257
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : September 14, 2010
Information provided by:

July 3, 2009
July 7, 2009
September 14, 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) ]
Same as current
Complete list of historical versions of study NCT00933257 on Archive Site
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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.

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Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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.

Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Medical Affairs Study Director, sanofi-aventis
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Study Director: Jaderson Lima Sanofi
September 2010

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