Induced Dryness Stress on Human Vaginal Epithelium: The Efficacy of a New Vaginal Gel.

Guglielmo Stabile,Francesco De Seta,Giuseppe Ricci,Maria Sole Scalia

doi:10.3390/gels7040157

Guglielmo Stabile, Francesco De Seta + Show 2 more

Open Access

https://doi.org/10.3390/gels7040157

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Abstract

An experimental model of dryness on vaginal mucosa is proposed to assess the efficacy of a new vaginal gel (Respecta® Hydragel Ref 17031). The dryness model was induced on reconstituted human vaginal epithelium (HVE) by incubating the tissues in modified environmental conditions (R.H. < 50% and T = 40 °C) for 48 h. The products were applied on the ‘Dry’ HVE models for 24 h (series 48 h + 24 h) in standard culture conditions (37 °C 5% CO2). Their efficacy in counteracting vaginal dryness was assessed and compared to tissues treated with saline solution and cultured in standard culture conditions (negative control) and to untreated tissues incubated in dryness conditions for 48 h and then recovered after 24 h in standard culture conditions (positive control). The products’ efficacy was quantified by measuring the following parameters: (1) water flux and direct moisturization by AQP3 immunohistochemical staining, and (2) maintenance of moisturization and elasticity of the mucosa by hyaluronic acid (CD44) immunofluorescence staining. Respecta® Hydragel demonstrated efficacy in regulating the water flux by inducing AQP3 expression thus determining a positive water balance within the vaginal epithelium. It induced a remodelling of the epithelium morphology with restored trophism compared to the dry HVE control. Furthermore, it demonstrated a significant increase of the expression of CD44, related to hyaluronic acid (HA) distribution in the extracellular matrix. HA has the ability to act on the cellular matrix composition and its renewal compared to the dry HVE control. Through these mechanisms it induces a deep hydration and elasticity of the vaginal mucosa.

Highlights

Menopause generally arises in the fourth or fifth decade of life resulting in lower levels of circulating estrogen
The tissue used for the experiments is not an expiant for human subjects; it is a commercial reconstituted human vaginal epithelium (HVE) purchased from EPISKIN Laboratoires, 4 Rue Alexander Fleming 69366
In order to do so, we evaluated four tissue models: a negative control (HVE tissue treated with 10 μL of saline solution and incubated in standard culture conditions for 48 h) was compared to a positive control and to two treated tissues, respectively with Respecta Hydragel and with placebo. (Figures 1 and 2)

Summary

Introduction

Menopause generally arises in the fourth or fifth decade of life resulting in lower levels of circulating estrogen. Such deficit is accountable for symptoms such as hot flushes, night sweats, decreased cognitive functions, mood changes and genitourinary tract alterations associated with vulvovaginal atrophy (VVA). In VVA there can be found many signs and the most common include dryness, redness, itching, pain at intercourse, and occasionally discharge or bleeding [6,7] Until now and for the past decades, the therapy mostly employed for the management of VVA and vaginal dryness in post menopausal women has been either systemic or with local low-dose estrogen therapy [8,9,10,11]. The prescription of vaginal moisturizers and lubricants together with the continuation of sexual activity may be helpful in improving their living standards

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