NCT00497783CompletedPhase 4
Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Clinical and local tolerability
Study Overview
Brief Summary
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- 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 considerations relevant to a patient's potential participation in a clinical trial.
Outcomes
Primary Outcomes
Clinical and local tolerability
Time Frame: 21 days
Adverse events and their association with the treatment.
Time Frame: 21 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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