Once the prototype approaches its final design, first test production runs are initiated to ensure the prototype can be converted into production. During this process of experimental production in the plant, the products are first made for further quality testing with women. At this stage, diary and technical perception testing may be conducted, during which women are supplied with the products and asked to wear them as they normally do. While wearing them, women are asked to keep a diary about their wearing experience: how well the product met their protection expectation and how comfortable the product was during actual use.
Another type of controlled panel test is the clinical test, which is conducted to assess the safety of using the product. The safety assurance program to support major innovations for feminine hygiene products often requires the performance of prospective, randomized, controlled clinical trials under practical conditions of use. The studies often share several common features and standard protocols are developed with the input of respected academic and medical experts. The protocols employ objective, numerical scales for assessing tissue irritation and skin condition of the external and internal genitalia. All clinical studies must be approved by an independent institutional review board and/or by an ethics committee and should be examiner-blinded, utilizing independent academic physicians in obstetrics, gynecology, or dermatology as investigators. Subjects can be recruited from the population at large, and must sign an informed consent form before participating (1).
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The term vaginitis is one that is applied to any inflammation or infection of the vagina, and there are many different conditions that are categorized together under this ‘broad’ heading, including bacterial vaginosis, trichomoniasis and non-infectious vaginitis.