Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation
This study has been completed.
Information provided by:
First received: July 3, 2009
Last updated: September 13, 2010
Last verified: September 2010
To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd Silver Floral.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Floral (Lactic Acid).|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according 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 ]
|Study Start Date:||June 2009|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Dermacyd Silver Floral (Lactic Acid)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.
Drug: LACTIC ACID(ND)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative during 5 weeks (treatment period).
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