ORAL MUCOSITIS – Orosol
Physiopathology:
Oral mucositis is a very common side effect of cancer chemotherapy. The oral mucosa being one of the fastest growing tissues in the body, cytostatic effect of cancer therapies on oral mucosa cells blocks cellular growth and causes mucositis lesions which cannot heal as long as the cancer treatment continues.
>20 proteolytic enzymes (MMPs) are secreted to clean the ulcers but they also destroy the cellular matrix & stop cell growth. Microbial growth starts, circulating chemicals infiltrate the lesions, causing severe irritation & pain, and the patient suffers until anti-cancer treatment is stopped.
Ideal Treatment Approach:
Must be MULTI-TARGET. It should:
1. Clean the ulcer of microbial contaminants
2. Remove impurities or undesirable particles which interfere with cellular growth and therefore prevent ulcer healing
3. Remove continuously the toxic infiltrating chemicals to minimize pain & irritation.
20mL Class I Medical Device for the treatment of Radiotherapy & Chemotherapy-induced Oral Mucositis
Currently Available Treatments:
Only symptomatic treatments (antiseptics, anesthetics, growth factors…)
VITROBIO‘s Completely NEW Therapeutic Approach:
Provide a clean, hydrated microenvironment to allow ulcer healing and reduce pain.
In 1994, Vitrobio discovered & patented a hypertonic viscous liquid solution, based on a polyol, 18 times more osmotically active than sea water yet NON-IRRITANT, capable of generating an instant flow of hypotonic liquid when applied on a live biological, semi-permeable, membrane (International patent 1997: PCT/FR99/01340). Applying this solution on the ulcers cleans the injury of all the contaminants present on the ulcers within a few minutes. The filmogen capacity of this solution was enhanced by cross linking polyol molecules with specific natural polymers to resist local movements (2013 patent: PCT/EP2013/061835).
MODE OF ACTION:
When applied as a thin layer on the Mucositis ulcers, OROSOL instantly forms a hypertonic film which creates a strong outward flow of hypotonic liquid, instantaneously detaching all the contaminants, healing-impeding impurities, and infiltrating chemicals from the injury. A clean environment reduces pain, promotes an ideal environment for partial ulcer healing, and minimizes new ulcer formation & expansion. (For detailed mode of action: please contact Vitrobio)
Product Presentation: 20mL Spray.
Posology: 4-5 sprays every 2 h in the beginning of treatment, then 3-4 times a day.
Regulatory Status: Due to the mechanical topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structure: Class I (soon Class II) Medical Device in Europe.
Contraindications: Not to be used in the pediatric population under 6 years of age.
Side Effects: Slight burning sensation for about 1 min following product application.
Clinical Efficacy:
Full trial published in Journal of Cancer Research and Treatment, 2013, Vol. 1, No. 1, 4-11: A New Therapeutic Approach to Treat Oral Mucositis Using Specific MMP Blockers in an Osmotically Active Solution
