Hygiene Clinical Trial
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).
Verified date | September 2010 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion criteria: - Phototype 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 pregnancy - Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection - Diseases which can cause immunosuppresion, such as diabetes, HIV - Personal history of atopy - History of sensitivity or irritation for topic products - Cutaneous active disease (local and/or general) which can modify the study results - Use of new drugs and/or cosmetics during the study - Cutaneous reaction - Previous participation in studies using the same product in test - Volunteer which has immunodeficiency congenital or acquired - Relevant history or confirmation of alcohol or other drugs abuse - Intolerance detected or suspected for some component of the sample tested - Medecin or sponsor employees or their close family. 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/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Sanofi-Aventis Administrative Office | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
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