Hygiene Clinical Trial
Official title:
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermal Irritability, Dermal Sensitivity) of Dermacyd Teen Care Tangerina Mix .
Verified date | May 2009 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Teen Care Tangerina Mix.
Status | Completed |
Enrollment | 51 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Phototype Skin I,II, III e IV - Integral skin test in the region Exclusion Criteria: - Lactation or gestation - Use of Anti-inflammatory and/or immuno-Supression drugs 1 month before the study - Personal history of atopy - History of sensitivity or irritation for topic products - Active cutaneous disease - Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Brazil | Sanofi-Aventis Administrative Office | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The absence of primary and accumulated dermal irritability will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. | Throughout the study | No |
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