Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.
|ClinicalTrials.gov Identifier: NCT00933075|
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : September 14, 2010
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.
|Condition or disease||Intervention/treatment||Phase|
|Hygiene||Drug: LACTIC ACID(ND)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Frutal (Lactic Acid).|
|Study Start Date :||June 2009|
|Primary Completion Date :||July 2009|
|Study Completion Date :||July 2009|
Experimental: Dermacyd Silver Frutal (Lactic Acid)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also usedas a control sample.
Drug: LACTIC ACID(ND)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).
- Measure of the photo irritation test and the photosensitivity by using 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933075
|Sanofi-Aventis Administrative Office|
|Sao Paulo, Brazil|
|Study Director:||Jaderson Lima||Sanofi|