Status:
COMPLETED
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation
Lead Sponsor:
Sanofi
Conditions:
Hygiene
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Phototype Skin II and III;
- 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 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 of photodermatosis active;
- Family or personal antecedent of cutaneous photoinduced neoplasias;
- Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses 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.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00785720
Start Date
August 1 2008
End Date
September 1 2008
Last Update
August 25 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
São Paulo, Brazil