Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional

Study Overview
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Brief Summary
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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.

Official Title
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Single Center, Open, Cross-over, Phase III Study for Safety and Efficacy (Subjective and Instrumental) Comparative Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional for Intimate Use in Menopauses Woman.

Conditions
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Hygiene

Intervention / Treatment
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* Drug: Dermacid Silver (Lactic acid)
* Drug: Glycerine Vegetal Soap Granado Traditional


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional | Drug: Dermacid Silver (Lactic acid)<br>* Liquid soap, daily use<br>Drug: Glycerine Vegetal Soap Granado Traditional<br>* Vegetal soap, daily use<br>|
| Experimental: Group 2<br>Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR | Drug: Dermacid Silver (Lactic acid)<br>* Liquid soap, daily use<br>Drug: Glycerine Vegetal Soap Granado Traditional<br>* Vegetal soap, daily use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal water loss measurement (TEWL) and corneometry | 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. | Up to Week 9 |