Hygiene
Conditions
Brief summary
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.
Interventions
Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 20 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and their intensity and their association with the treatment | 21 days |
Countries
Brazil
Outcome results
None listed