ORAL ULCERS – APHTAPLUS
Physiopathology:
Nearly 10% of the world population regularly suffers from oral ulcers (canker sores). In theory, ulcer healing is extremely easy as it simply requires killing the bacterial cells on one hand and stimulating the growth of new healthy cells inside the ulcer on the other hand. Until now, there was no single treatment with these two opposite yet complementary properties.
Ideal Treatment Approach:
Stimulate instant cell growth by: 1. Cleaning the live biological surface of all contaminants and chemicals 2. Removing all the impurities from the ulcer 3. Keeping the surface hydrated to help alleviate the pain and drying of tissues, within the shortest period. (4) Minimizing the concentration of all undesired proteins in the ulcer cavity.
10 ml Class I Medical device for the Treatment of Oral Ulcers (Canker Sores)
1st Cleaning & Healing Topical Gel for the Treatment of Canker Sores and Traumatic Oral Ulcers
Currently Available Treatments:
Only symptomatic.
- Topical: Antiseptics, alcohol preparations, anesthetics, protective gels.
- Systemic: Antibiotics (rarely used)
VITROBIO‘s Approach:
A CLEAN INJURY HEALS VERY FAST
In 1994, Vitrobio discovered & patented a highly osmotic solution capable of generating an instant flow of hypotonic liquid when applied on a live biological, semi-permeable, membrane (PCT/FR99/01340). Applying this solution on the ulcers cleans the injury of all the contaminants within a few minutes. The filmogen capacity of this solution was enhanced by incorporating specific glycerol binding polymers to render it stable for 4-6h and able to resist local movements (PCT/EP2013/061835) for a long-lasting action. Cleaning the ulcer mechanically of all the contaminants with a cell friendly osmotic film stimulates instant cell growth & ulcer healing.
MODE OF ACTION:
APHTAPLUS is a viscous, osmotically active, mechanically acting hypertonic solution. When applied on the mouth ulcer, APHTAPLUS forms a film over the lesion and mechanically attracts hypotonic fluid present below the injured surface. This strong outward flow of liquid clears the injury of all the contaminants (dead cells, cell debris, bacterial particles, food particles…) to reduce microbial exposure. Cleaning the wound and reducing the contaminants creates a favorable environment for cell growth & healing. The film also protects the ulcer against external aggressions and thereby reduces irritation and pain. A clean injury is less painful and heals very fast. (For detailed mode of action, please contact VITROBIO)
Product Presentation: 10mL Tube.
Directions: Topical application of a few drops, directly on the lesion so as to form a film on its entire surface, 3-4 times per day up to complete healing.
Regulatory Status: Due to the mechanical topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structure: Class I Medical Device in Europe.
Contraindications: Not to be used in the pediatric population under 3 years of age.
Side Effects: Slight burning sensation for about 1 min following product application.
Clinical Efficacy:
Full trial published in Clin Drug Investig. 2006;26(10):567-73: Treatment of common mouth ulcers with topical Alchemilla vulgaris in glycerine (Aphtarine®)
Full trial published in Wiley InterScience, 2007: Effects of Alchemilla vulgaris and Glycerine on Epithelial and Myofibroblast Cell Growth and Cutaneous Lesion Healing in Rats
