Hygiene
Conditions
Brief summary
Primary Objective: \- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional Secondary Objective: \- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.
Interventions
Route of administration: local
Route of administration: local
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Perfect mucosa in the product analysis region * Volunteers with active sexual life: normal Papanicolau test performed less than one year is mandatory * Bacterioscopy describing the vaginal flora * Negative Trichomonas vaginalis test * Negative Whiff test * Willingness in using preservative in the sexual intercourse during the study period * Use the same category cosmetics products * Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion
Exclusion criteria
* Use of antiinflammatory / immunosuppression / antihistaminic drugs * Atopic or allergy history to cosmetic products * Active cutaneous disease (local and/or disseminated) in the evaluated area * Disease which can cause immunosuppression, such as diabetes, HIV, etc. * Endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs * Intense solar exposure (to get a tan) during the 15 days before the evaluation * Gynecologic treatment until four weeks before the evaluation * Any vaginal infection detected during the inclusion * Other conditions considered by the investigator as reasonable for exclude the patient in the study. 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 | Description |
|---|---|---|
| Reduction of genital odor and increase hydration in genital mucosa | From the treatment start to the end of the study (day 67) | Patient's questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the integrity of the mucosa | From the treatment start to the end of the study (day 67) | Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated. |
Countries
Brazil
Outcome results
None listed