NCT00712868
Completed
Phase 4
Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina
Overview
- Phase
- Phase 4
- Intervention
- Lactic acid
- Conditions
- Hygiene
- Sponsor
- Sanofi
- Enrollment
- 559
- Locations
- 1
- Primary Endpoint
- Clinical and local tolerability
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
To demonstrate the safety and acceptability of the gynaecological formulation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Integral skin in the tested region
Exclusion Criteria
- •Pregnancy or breastfeeding women
- •Use of anti-inflammatory or immune-suppression drugs
- •Topical medication use at the tested region
- •Active cutaneous gynaecological disease which may interfere in study results
- •Personal history of allergic disease at the area to be treated
- •Allergic or atopic history
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Arms & Interventions
1
Lactic Acid once a day during 21 days
Intervention: Lactic acid
Outcomes
Primary Outcomes
Clinical and local tolerability
Time Frame: After 21 days
Study Sites (1)
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