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Primary Objective:
To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermacyd Silver Frutal (Lactic Acid) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LACTIC ACID(ND) | Drug | Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale. | from the treatment start to the end of the study (treatment period 6 weeks) |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Jaderson Lima | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | São Paulo | Brazil |
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