Status:
COMPLETED
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
Lead Sponsor:
Sanofi
Conditions:
Hygiene
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief Summary
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.
Eligibility Criteria
Inclusion
- Phototype Skin II and III;
- Integral skin test in the region;
Exclusion
- Lactation or gestation;
- Use of Anti-inflammatory and/or immuno-suppression 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 :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00705744
Start Date
April 1 2008
Last Update
April 15 2009
Active Locations (1)
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1
Sanofi-aventis
São Paulo, São Paulo, Brazil