NCT00712868CompletedPhase 4
Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 559
- Locations
- 1
- Primary Endpoint
- Clinical and local tolerability
Study Overview
Brief Summary
To demonstrate the safety and acceptability of the gynaecological formulation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Experimental
Lactic Acid once a day during 21 days
Intervention: Lactic acid (Drug)
Outcomes
Primary Outcomes
Clinical and local tolerability
Time Frame: After 21 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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