Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze
Phase 3
Completed
- Conditions
- Hygiene
- Interventions
- Drug: Lactic acid (Dermacid)
- Registration Number
- NCT00664391
- Lead Sponsor
- Sanofi
- Brief Summary
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Breeze.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
Inclusion Criteria
- Integral skin test in the region;
Exclusion Criteria
- Lactation or gestational risk or gestation;
- Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
- Topical medication use at the region to be treated;
- Cutaneous disease or active gynecological 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Lactic acid (Dermacid) -
- Primary Outcome Measures
Name Time Method Adverse events and their intensity and their association with the treatment. 21 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-aventis
🇧🇷São Paulo, Brazil
Sanofi-aventis🇧🇷São Paulo, Brazil