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

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

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

METHODS: Clinical and in-vitro studies were performed on organic cotton pads in order to assess if their use can pre-
vent 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 cot-
ton 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 physiologi-
cal activities of the tissue substrates.

(Cite this article as: Mori M, Praticò A, Villa R, Buzzella A, Vicini R, Busoli Badiale S, et al. Evaluation of safety and skin
tolerability of organic cotton pads in case of irritative vulvitis. Minerva Ginecol 2018;70:729-37. DOI: 10.23736/S0026-