Status:
COMPLETED
Dermacyd Infantile (Lactic Acid)- Compatibility.
Lead Sponsor:
Sanofi
Conditions:
Hygiene
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Photo type Skin I,II, III e IV
- Integral skin test in the region
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.
- Exclusion criteria:
- Lactation or gestation
- Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
- Diseases which can cause immunity decrease, such as HIV, diabetes
- Previous atopy
- History of sensitivity or irritation for topic products
- Active cutaneous diseases which can interfere in the study results
- Use of new drugs and/ or cosmetics during the study
- Cutaneous reactivity
- Previous participation in studies, which had used the product
- Volunteers who have immunodeficiency congenital or acquired
- Relevant clinical history or present evidence of alcohol abuse or others drugs
- Non tolerance to some component of the study product.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00881374
Start Date
February 1 2009
End Date
March 1 2009
Last Update
April 15 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
São Paulo, Brazil