Hygiene Clinical Trial
Official title:
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.
Verified date | December 2010 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Sanofi-Aventis Administrative Office | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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