Dermacyd Silver Frutal (Lactic Acid) - Compatibility.
|ClinicalTrials.gov Identifier: NCT00933946|
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : September 14, 2010
To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) 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 :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study for Dermatological Evaluation of Topic Compatibility Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Frutal (Lactic Acid).|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2009|
|Actual 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 used as a control sample.
Drug: LACTIC ACID(ND)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.
- Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: from the treatment start to the end of the study (treatment period 6 weeks) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933946
|Sanofi-Aventis Administrative Office|
|Sao Paulo, Brazil|
|Study Director:||Jaderson Lima||Sanofi|