Dermacyd Silver Frutal (Lactic Acid) - Compatibility.
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 irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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).|
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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) ] [ 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 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.
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