Status:
COMPLETED
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal
Lead Sponsor:
Sanofi
Conditions:
Hygiene
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Primary Objective: To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd PHDESILSTYFR.
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 pregnancy
- Use of Antiinflammatory 30 days and/or immunossupression drugs until 3 months before volunteers selection
- Disease which can cause immunosuppresion, such as diabetes, HIV
- Concomitant use of photosensitivity drugs
- History of sensitivity or photosensitivity with topic products
- Cutaneous active disease which can modify the study results
- History or activity of photodermatosis
- Personal or family antecedents of cutaneous neoplasia photo induced
- Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
- Intense exposure solar in the test region
- Use of new drugs and/or cosmetics during the study
- Previous participation in studies using the same product in test
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00933257
Start Date
June 1 2009
End Date
July 1 2009
Last Update
September 14 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
São Paulo, Brazil