The vaginal epithelium is soft and supple thanks to a delicately balanced mechanism that maintains hydration and lubrication.
At certain times during a woman’s lifetime, such as after childbirth, during breastfeeding or in menopause, after taking some medicines including oral contraceptives or at times of particular stress, this delicate balance may be upset, causing the vaginal walls to lose moisture and elasticity. This results in considerable discomfort characterised by a burning or itching sensation, or pain especially during sex.
Burning and irritation are often what a woman feels when friction caused by lack of lubrication causes tiny lesions to the epithelium. In such cases, specific pharmacological treatment may be prescribed, but a local product that rehydrates the mucosa and helps to restore natural suppleness may also be recommended. Vaginal moisturisers, which are water based, are available as liquids, gels, or ovules inserted every few days. Vaginal moisturisers can be safely used in the long term, and need to be used regularly to achieve an optimal effect.
Hyalofemme is a class II Medical Device (CE Certification) with proven efficacy through clinical and pre-clinical studies. Its principal component is Hydeal-D®, a unique, patented Low Molecular Weight (LMW) version of Hyaluronic Acid (HA).
HA is a natural lubricating and moisturising substance found in the skin and around joints, and is widely used in skincare and medical products due to its excellent biocompatibility and hydrating properties. HA can absorb many times its own weight in water.
Hydeal-D® results from the partial esterification of the carboxylic acid groups of HA with benzyl alcohol. It is formulated to resist enzymatic breakdown, giving Hyalofemme a long-lasting moisturising effect. When in contact with the vaginal mucosa esterase, Hydeal-D® is degraded into native HA. Thanks to the controlled release of LMW HA, which is small enough to pass the cell membrane, water is released for a long period of time inside the cell, as opposed to simply adding moisture to the vaginal cavity, as most products do.
Two important characteristics of vaginal moisturisers are pH value and osmolality. Ideally a vaginal lubricant should have a pH of about 4.5. The pH value of Hyalofemme is 4.9; therefore this value meets the World Health Organisation’s advisory note. The osmolality experimentally determined by Fidia Pharmaceutici on the Hyalofemme gel is about 1300 mOsm/kg. This value is significantly lower compared to other commercially available gels that are moderately hyperosmotic and that can cause mild irritation.
Hyalofemme also provides a high degree of muco-adhesiveness and enhances the natural healing processes of the epithelium to provide fast, long-lasting relief even in the case of microlesions. Both Carbopol and HA are mucoadhesive; HA is in fact an excellent adhesive with characteristics comparable to Carbopol. Hydeal-D as a derivative of HA has demonstrated to have the best mucoadhesive properties and exhibited similar in vivo properties.
There is pre-clinical data to suggest that Hyalofemme can reverse vaginal atrophy, and it stimulates T-cell receptors to induce self-defence mechanisms in the vaginal epithelium, helping to protect against potential infections.
Therefore, Hyalofemme offers fast relief of symptoms in the short term and helps to maintain vaginal health and comfort in the long term. Hyalofemme has a lasting effect on dryness and only needs to be applied once every three days, although it can be applied as required, should additional lubrication be necessary.
Please contact us for more information about the scientific studies.