Gelclair® is a viscous, concentrated, bioadherent oral gel, indicated for the management of painful symptoms associated with oral lesions of various etiologies, including oral mucositis/stomatitis, irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures or diseases. It is also indicated for diffuse aphtous ulcers.
One of the most severe conditions of painful oral lesions is represented by oral mucositis which is characterised by recurrent, erythematous, painful ulcers, and is a common complication of standard and high-dose chemotherapy or radiotherapy in head and neck cancer. Besides the discomfort and pain caused, mucositis leads to difficulties in the intake of food and fluid, causing dehydration and malnutrition and it could lead to a higher risk of infections.
The most common forms of oral mucositis treatment include local anaesthetics, corticosteroids, systemic analgesics, systemic or topical anti-inflammatory drugs, antimicrobial agents.
Gelclair® exerts its pain-relieving effect by forming a protective layer over the oral mucosa and by lubricating, hydrating, and coating the damaged tissues without numbing, stinging, or drying. This protective barrier shields the exposed and sensitised nerve endings in the mucosa from over-stimulation and provides rapid oral pain relief.
This improves the patient’s ability to eat and drink, thus ameliorating patient’s quality of life during the course of chemo- or radiotherapy.

In clinical trials Gelclair® showed good results in pain relief and in improving the ability of the patients to eat and drink; the product resulted very well-tolerated and well accepted for the taste, smell and easiness to use. No interactions are known to exist with medicinal products.

The key ingredients of Gelclair® are polyvinylpyrrolidone, hyaluronic acid, and glycyrrhetinic acid.
These ingredients are well known, extensively used substances.

Regulatory status 

In the European Union and Switzerland Gelclair® is classified as a medical device and its conformity to this directive is certified by the CE mark.
In the USA, Gelclair® is classified as a 510K prescription product (Medical Device) by the FDA and is reimbursed.
Overseas countries as Australia and Israel classified the product as medical device.

How to use Gelclair®

Gelclair® is available in a concentrated form to be diluted with water.
The solution obtained diluting the concentrated form should be rinsed around the mouth in order to cover all the oral tissues for at least one minute, gargled and spat out.
The patient should avoid eating and drinking for at least one hour following treatment.