Status:
COMPLETED
Dermacyd Tina Gel Tangerina Mix - Photo Evaluation
Lead Sponsor:
Sanofi
Conditions:
Healthy
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Tangerina Mix.
Eligibility Criteria
Inclusion
- Phototype Skin II and III
- Integral skin test in the region
Exclusion
- Lactation or gestation
- Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
- Diseases which can cause immunity decrease, such as HIV, diabetes
- Use of drug photosensitizer
- History of sensitivity or irritation for topic products
- Active cutaneous disease which can change the study results
- History or photodermatosis active
- Family or personal antecedent of cutaneous photoinduced neoplasias
- Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
- Intense solar exposure in the study area
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00668889
Start Date
November 1 2007
Last Update
January 29 2009
Active Locations (1)
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1
Sanofi-aventis administrative office
São Paulo, São Paulo, Brazil