Abstract
We compared the skin compatibility of two menstrual pad technologies in a single-center, parallel, randomized, examiner-blinded study involving adult women. This report presents the results of a subset of 10 participants who had a genital infection within 12 months prior to the start of the study. In a blinded fashion, participants were randomized to receive one of the two pads for use over two menstrual periods. Participants' skin erythema was graded 24–48 hours following cessation of menstrual flow and on day 14 of each menstrual cycle. Participants subjectively reported any sensory effects. Vulvar erythema scores for the mons pubis, labia majora, labia minora, perineum, buttocks, left medial thigh, and right medial thigh assessed after both menstrual cycles were not statistically different between groups or between the two different products. A low incidence of itching and burning occurred in both groups without statistical significance; none of the participants experienced a recurrent or new genital infection. These preliminary results show that participants with recent genital infections included in clinical studies do not exhibit greater vulvar erythema or sensory effects than participants without recent genital infection. The study showed that the safety profile of the products tested remained acceptable in women with recent genital infection.
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