Avaliação comparativa de segurança e eficácia para produtos de higiene íntima em mulheres na menopausa
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Background and objective: The menopause is the last menstrual period. A milestone in the climacteric, when major changes occurs in women's lives. The aim of this study was to evaluate the safety and efficacy in moisturizing and recovery of genital mucosa for hygiene products in menopause women. Method: Study involving 70 female volunteers, age 45 to 65 years, distributed in two groups of 35 members. Each group received one fragrance of the investigational product for 15 days and then was added a moisturizing lotion to the investigational product for more 15 days. After 7 days of wash-out period the volunteers used the comparative product for more 30 days. Evaluation of efficacy was performed by instrumental measurements as Transepidermal Water Loss (TEWL) and Corneometry. Subjective evaluations were performed through the questionnaires at the beginning and end of each treatment with the products. At the end of study, a questionnaire was answered comparing directly the treatments. Results: The comparative product showed better results, statistically significant, than the investigational product fragrance Silver Frutal in sensation of elasticity and firmness of the mucosa. The addition of the moisturizing lotion in both investigational products fragrances Silver Frutal and Floral brought positive results to all parameters evaluated, except to viscosity. As for the safety, none of the volunteers had allergic reaction or other adverse event. Conclusion: The hygiene products for the female genital region should preserve the physiological condi. © Copyright Moreira Jr. Editora.Todos os direitos reservados.
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Portuguese
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Revista Brasileira de Medicina, v. 70, n. 10, 2013.
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