MUCOSITIS OROSOL : treatment of oral mucositis induced by radiotherapy or chemotherapy.
MucositisOROSOL is an innovative oral spray designed to treat oral mucositis induced by radiotherapy or chemotherapy. With its protective barrier effect, osmotic and cleaning effect, as well as cellular repair and growth effect, MucositisOROSOL provides a significant reduction in pain, burns, infections, and mucositis in as little as 20 minutes. Clinical results show continued improvement with regular use, offering patients long-lasting relief and improved quality of life.
MucositisOROSOL is a revolutionary product designed to provide relief and treatment for oral mucositis induced by radiotherapy or chemotherapy. This throat spray, presented in a 20ml bottle, targets pro-inflammatory proteins, contaminants, and impurities, offering a threefold action for optimal results.
Protective Barrier Effect:
MucositisOROSOL creates a protective barrier in the oral cavity, shielding the mucous membranes from further damage and allowing the healing process to begin.
Osmotic and Cleaning Effect:
The product works to cleanse the oral cavity, removing impurities and contaminants that can exacerbate inflammation and delay healing.
Cellular Repair and Growth Effect:
MucositisOROSOL promotes the repair and growth of cells in the oral cavity, accelerating the healing process and reducing the duration of symptoms.
In a randomized, double-blind, placebo-controlled clinical trial conducted over six weeks, MucositisOROSOL demonstrated significant efficacy. Patients experienced a 23% reduction in mucus in just two days, and a 35% reduction in mucositis in three days. By the end of one month, mucositis was reduced by 69%.
The product also showed remarkable results in pain management, with a 34% reduction in pain in just 20 minutes, and a 72% reduction in pain by the end of one month.
In addition to its effects on mucositis and pain, MucositisOROSOL also demonstrated a significant reduction in burns and infections associated with oral mucositis. By the end of one month, burns were reduced by 74%, and infections were reduced by 75%.
These results highlight the potential of MucositisOROSOL as a powerful tool in the management of oral mucositis induced by radiotherapy or chemotherapy. Its multi-faceted approach not only alleviates symptoms but also promotes healing, offering patients a more comfortable and swift recovery.
Oral Mucositis: A Debilitating Complication of Cancer Treatments
Understanding Oral Mucositis
Oral mucositis is a common and debilitating oral complication of cancer treatments, including chemotherapy, radiotherapy, and hematopoietic stem cell transplantation. It is characterized by the presence of ulcers in the oral mucosa that cause pain, bleeding, and difficulty in ingesting fluids and solids, or speaking. This leads to impairment of basic oral functions and could result in unplanned treatment interruption or modification. As such, oral mucositis negatively impacts both patients’ quality of life as well as tumor prognostic outcomes.
The Pathophysiology of Oral Mucositis
The pathophysiology of oral mucositis has been widely studied over past decades with several pathways related to oxidative stress, inflammation, and molecular and cellular signaling being implicated. Recent studies have also highlighted the emerging role of the oral-gut microbiome axis in the development of oral mucositis. Particularly, alterations in the oral and gut microbiota as well as intestinal dysfunction caused by cancer treatments could contribute to the pathogenesis of oral mucositis.
Oral Mucositis in Children Undergoing Cancer Treatment
In children who receive chemotherapy for cancer, oral mucositis is a common and painful side effect that decreases quality of life and treatment adherence. The oral microbiota undergoes a substantial dysbiosis as an effect of cancer and its treatment, characterized by lower richness and less diversity. Furthermore, this dysbiosis seems to promote pro-inflammatory cytokine release and pro-apoptotic mediators, enhancing the oral tissue damage.
CLAIMS IN LINE WITH THE NEW REGULATION
CLINICAL TRIAL
General informations
Title : A New Therapeutic Approach to Treat Oral Mucositis Using Specific MMP Blockers in an Osmotically Active Solution
Journal : Clinical Trials | 2013
TYPE OF TRIAL: Randomized clinical trial | 4 weeks
PATIENTS: N= 69 | Test product = 48 ; Comparator = 21
INCLUSION: Patients under recent chemotherapy, radiotherapy, or both, and suffering from mild to severe mucositis.
Link: 9-Oral Mucositis-Clin – J Canc Res Treat
MAIN RESULTS
The results showed that Orosol® was highly effective in reducing pain, burning sensation, infection, and overall oral ulcerative condition. There was a progressive reduction in the infection score in the Orosol® group after the first application, up to day 21. Although the product was less effective in inhibiting the formation of new ulcers, it led to a slow and progressive improvement in patients’ capacity to eat a soft diet. By the end of the study, 85% of patients in the Orosol® group were able to take in a soft diet.
No other undesirable events were attributed to the treatments in any of the patients, except for the initial burning sensation followed by excessive salivation during the first 1-2 minutes after each Orosol® application.
| Indication | Filmogen liquid bandage for the treatment of oral mucositis induced by radiotherapy or chemotherapy. |
| Composition | Filmogenic glycerol, honey, water, association of Vaccinium macrocarpon and Vaccinium myrtillus. |
| Presentation | Throat spray 20ml |
| Class | MDD Class I | MDR Class IIa |
| Direction | Apply 2 sprays in throat, 2-3 times a day. |
| Precautions | For topical use only (oral cavity). Keep out of reach and sight of children. |
| Age | 18+ |
| Storage conditions | Below 25°C |
| Legal manufacturer | VITROBIO (France) |
| Product code | OS |