Dermacyd Infantile (Lactic Acid)- Compatibility.
Study Details
Study Description
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 Infantile.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Dermacyd Infantile (Lactic Acid) six weeks treatment |
Drug: LACTIC ACID(ND)
Dermacyd Infantile (Lactic Acid)
|
Outcome Measures
Primary Outcome Measures
- The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [During 6 weeks (i.e. treatment period)]
Eligibility Criteria
Criteria
Inclusion criteria:
-
Photo type Skin I,II, III e IV
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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:
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Lactation or gestation
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Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
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Diseases which can cause immunity decrease, such as HIV, diabetes
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Previous atopy
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History of sensitivity or irritation for topic products
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Active cutaneous diseases which can interfere in the study results
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Use of new drugs and/ or cosmetics during the study
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Cutaneous reactivity
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Previous participation in studies, which had used the product
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Volunteers who have immunodeficiency congenital or acquired
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Relevant clinical history or present evidence of alcohol abuse or others drugs
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sanofi-Aventis Administrative Office | Sao Paulo | Brazil |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Jaderson Lima, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LACAC_L_04679