ORIGINAL ARTICLE   Free access

Minerva Ginecologica 2018 December;70(6):729-37

DOI: 10.23736/S0026-4784.18.04338-1

Copyright © 2018 EDIZIONI MINERVA MEDICA

language: English

Evaluation of safety and skin tolerability of organic cotton pads in case of irritative vulvitis

Michela MORI ¹ ✉, Antonella PRATICÒ ¹, Roberta VILLA ¹, Alice BUZZELLA ¹, Riccardo VICINI ¹, Silvia BUSOLI BADIALE ¹, Ornella PASTORIS ², Claudio ANGELINETTA ¹, Maurizio BARBIERI CARONES ³

¹ Bio Basic Europe Srl, Milan, Italy; ² Department of Biology and Biotechnology L. Spallanzani, University of Pavia, Pavia, Italy; ³ Private Practitioner, Milan, Italy

BACKGROUND: The woman vaginal environment is a fragile and delicate ecosystem that is often impaired by physical and chemical agents. This condition tends to damage skin barrier causing allergic reactions that lead to chronic irritating conditions.
METHODS: Clinical and in-vitro studies were performed on organic cotton pads in order to assess if their use can prevent the onset of irritant conditions. During clinical studies, the panelists’ skin and mucosae state were checked through a gynecological clinical examination in order to assess tissue dryness and alterations. Moreover, each panelist answered a sensorial questionnaire at the end of the test. Data were gathered and the product acceptability of use was registered in terms of itching, irritations and burning feelings. The panelist score was calculated based on VNS Scale (0-10, where 0 is the minimum value and 10 is the maximum).
RESULTS: From a careful analysis of the first part of the study, it is possible to state that the tested product (organic cotton pads) has proved to reduce the onset of irritative phenomena and slight undesired effects caused by the conventional use of synthetic pads. In-vitro tests were conducted to study possible biological processes involved during allergic and sensitizing events produced by vulvitis. In particular, a pro-sensitizing test, a skin irritation on RHE (adapted from OECD 439) and tests to assess the soothing activity were performed on cell substrates.
CONCLUSIONS: Results demonstrated that organic cotton pads, in each part, are safe and do not impair any physiological activities of the tissue substrates.

KEY WORDS: Vulvitis - Menstrual hygiene products - Cotton fiber - Feminine hygiene products