Status:
COMPLETED
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal
Lead Sponsor:
Sanofi
Conditions:
Hygiene
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
Primary Objective: To prove the safety of the gynecological formulation in normal conditions of use.
Eligibility Criteria
Inclusion
- Exclusion criteria:
- Integral vaginal mucosa in the product analysis region
- Use the same category of cosmetics products
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time
- Exclusion criteria:
- Use of Anti-inflammatory, immunossupression or antihistaminics drugs
- Allergic or atopic history to cosmetics products
- Cutaneous active disease (local and/or general) in the evaluated area
- Disease which can cause immunosuppresion, such as diabetes, HIV
- Endocrinology pathology such as thyroid gland, ovary and adrenal gland
- Intensive solar exposure until 15 days before evaluation
- Gynecological treatment until four weeks before the study
- Other reason considered by the investigator as a reason for not being included.
- 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 :
32 Patients enrolled
Trial Details
Trial ID
NCT00932945
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