Dermacyd in Odor Reducing.

Study Overview
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Brief Summary
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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.

Official Title
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Single Center, Open, Cross-over, Phase III Study for Comparative Evaluation of Safety Use and Efficacy in the Odor Reduce and Vaginal Moisturize Increase for Intimates Use Products Dermacyd Femina Delicata, Dermacyd Femina Breeze, Dermacyd Teen Sweet Flower, Dermacyd Teen Fresh Mix and Dermacyd Femina Comparing to the Control Product Glycerine Vegetal Soap Granado Traditional.

Conditions
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Hygiene

Intervention / Treatment
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* Drug: LACTIC ACID (Dermacid)
* Drug: Glycerine Vegetal Soap Granado Traditional


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Dermacyd (different fragrances)<br>Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional | Drug: LACTIC ACID (Dermacid)<br>* Route of administration: local<br>Drug: Glycerine Vegetal Soap Granado Traditional<br>* Route of administration: local<br>|
| Active Comparator: Glycerine Vegetal Soap Granado Traditional<br>Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd) | Drug: LACTIC ACID (Dermacid)<br>* Route of administration: local<br>Drug: Glycerine Vegetal Soap Granado Traditional<br>* Route of administration: local<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of genital odor and increase hydration in genital mucosa | 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. | From the treatment start to the end of the study (day 67) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the integrity of the mucosa | Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated. | From the treatment start to the end of the study (day 67) |