Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional
NCT ID: NCT01126606
Last Updated: 2010-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2010-08-31
2010-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1
Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH\_DESYLSTY\_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional
Dermacid Silver (Lactic acid)
Liquid soap, daily use
Glycerine Vegetal Soap Granado Traditional
Vegetal soap, daily use
Group 2
Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH\_DESYLSTY\_FR
Dermacid Silver (Lactic acid)
Liquid soap, daily use
Glycerine Vegetal Soap Granado Traditional
Vegetal soap, daily use
Interventions
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Dermacid Silver (Lactic acid)
Liquid soap, daily use
Glycerine Vegetal Soap Granado Traditional
Vegetal soap, daily use
Eligibility Criteria
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Inclusion Criteria
* Menopause for at least 6 months
* Perfect mucosa in the evaluated area
* Use the same cosmetics category
Exclusion Criteria
* 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.
45 Years
65 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Countries
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Other Identifiers
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LACAC_L_04937
Identifier Type: -
Identifier Source: org_study_id