Hygiene
Conditions
Brief summary
Primary Objective: To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception. Secondary Objective: To evaluate the safety in normal condition of use.
Interventions
DRUGDermacid Silver (Lactic acid)
Liquid soap, daily use
Vegetal soap, daily use
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Active sex life * Menopause for at least 6 months * Perfect mucosa in the evaluated area * Use the same cosmetics category
Exclusion criteria
* Use of antiinflammatory / immunosuppression / antihistaminic drugs * Personal history of atopy to cosmetic products * Cutaneous active disease (local and/or general) in the evaluated area * Disease which can cause immunosuppression, such as diabetes, HIV * Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland * Intense solar exposure (to get a tan) during the 15 days before the evaluation * Gynaecologic treatment until four weeks before the evaluation * Whatever vaginal infection detected at time of inclusion * Other conditions considered by the investigator as reasonable to exclude the patient from 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 |
|---|---|---|
| Transepidermal water loss measurement (TEWL) and corneometry | Up to Week 9 | Measures taken at all visits by Tewameter equipment TM 300. The value of the average will be considered for analysis of final results. Corneometry: Measures taken at all visits by Corneometer equipment MPA 580. |
Countries
Brazil
Outcome results
None listed