Allerspray: medical device for the treatment of allergic rhinitis
ALLERSPRAY-G: Your Osmotic, Filmogen, and Non-Irritating Shield Against Environmental Allergens. Specially formulated nasal spray offering mechanical protection and contributing to the comfort of those suffering from allergic rhinitis.
Innovative Formulation
ALLERSPRAY-G is a Class IIa medical device (MDR) specifically designed to form an osmotic, stable, and non-irritating barrier against environmental allergens and contaminants. This unique formulation includes a blend of glycerol, solagum, tannin-rich plant extracts, and food-grade preservatives, ensuring a high-quality product that is both effective and safe for use.
Mode of Action for Allergic Rhinitis Treatment Products
Vitrobio’s allergic rhinitis treatment products work through a unique three-step process to provide relief from allergic rhinitis symptoms and promote healing.
Protective Barrier: The first step involves the creation of a protective barrier on the nasal mucous membrane. This is achieved through the use of filmogenic glycerol, which not only acts as a shield against incoming allergens and contaminants but also provides hydration and soothes the irritated nasal mucosa. This protective barrier is crucial in preventing further irritation and providing immediate relief.
Mechanical Cleaning: The second step is mechanical cleaning, which is facilitated by the product’s high osmotic activity. This osmotic action instantly attracts and traps most of the adhered contaminants, including inflammatory proteins and allergens. By removing these harmful substances, the product effectively suppresses inflammation and halts the immune cascade, leading to a reduction in allergic rhinitis symptoms.
Cellular Repair: The final step is cellular repair. Once the nasal mucosa is clean and hydrated, cell growth and healing are immediately triggered. This promotes the repair and regeneration of the nasal mucosa, leading to long-term relief from allergic rhinitis.
Through this three-step process, Vitrobio’s allergic rhinitis treatment products provide comprehensive treatment for allergic rhinitis, addressing both the symptoms and the underlying causes.
The mechanical osmotic action cleans, protects and hydrates. It thus promotes cell growth and repair. The polymers will also bind the target proteins. The film is then naturally removed.
Osmotic Properties
ALLERSPRAY-G also showcases osmotic properties. It assists in the removal of contaminants from the nasal mucosa, resulting in a cleaner and less irritated nasal surface. Its advanced formula works to attract hypotonic liquid from the nasal mucosa, detaching and draining free-floating contaminants.
Ease of Use
ALLERSPRAY-G is packaged as a handy, easy-to-use nasal spray. Its viscous, bandage-forming liquid is contained in a 15ml spray, providing approximately 125 sprays.
Defining Allergic Rhinitis
Allergic rhinitis, often referred to as hay fever, is an allergic response to specific allergens. This reaction causes symptoms like a runny or stuffy nose, sneezing, red, itchy, and watery eyes, and swelling around the eyes. The condition can be seasonal or perennial, where symptoms occur year-round.
Prevalence of Allergic Rhinitis
The prevalence of allergic rhinitis is increasing worldwide, affecting between 10-30% of the population. Globally, as many as 500 million people suffer from this condition, highlighting the widespread need for an effective treatment solution. Countries with higher levels of urbanization and lifestyle changes have seen a notable increase, making it a significant public health concern.
Impact on Quality of Life
The impact of allergic rhinitis extends beyond physical discomfort. It can significantly affect the quality of life, disturbing sleep, impairing daytime concentration, and limiting activities. It’s also a significant contributor to time off work and school.
Understanding the Triggers
Allergic rhinitis is triggered by allergens that include pollen, dust mites, mold, and animal dander. When a person with allergic rhinitis breathes in an allergen such as pollen or dust, the body releases chemicals, including histamine, causing allergy symptoms.
A Growing Market
With the rise in allergic rhinitis prevalence, the demand for effective and safe treatment methods is steadily increasing. This demand underscores the opportunity in the market for innovative solutions like ALLERSPRAY-G that offer novel approaches to managing this widespread condition.
The Need for Innovation
Despite the widespread prevalence of allergic rhinitis, many available treatments offer temporary relief from symptoms rather than preventing their occurrence. Innovations like ALLERSPRAY-G, with its preventative and mechanical mode of action, are crucial to improving the management of allergic rhinitis and enhancing the quality of life for those living with this condition.
CLAIMS IN LINE WITH THE NEW REGULATION
- Significative reduction of allergic symptoms
- Reduces nasal symptoms : congestion, rhinorrhea, sneezing, itching
- Reduces ocular symptoms : itching, tearing, redness
- Reduces the need for medication
- Mechanical mode of action
- Instant osmotic action
- Hydrates, protects and cleanses
- Protects the nasal mucosa against allergens
- Dual action: Relieves and protects
- Improves quality of life
- No drowsiness (compared to the placebo group)
- Non-addictive
Evidence-Based Design
ALLERSPRAY-G is designed and produced based on a wide range of meticulous scientific research. Clinical trials and numerous studies demonstrate its safety and efficacy. Key investigations include the selection of filmogen ingredients, proof of resistance of the film to mechanical pressures, absence of cytotoxicity of finished formulations, and barrier-forming properties against common allergens.
Proven Safety
Safety is our priority when it comes to health applications. ALLERSPRAY-G has undergone comprehensive regulatory studies defining its in vitro, in vivo toxicities, mutagenic potential, long-term stability, and in-use stability. Repeated applications during a 28-day trial showed no effect on hematological, blood-biochemical, urinary, organ weights, glycerol-related, and cellular (histopathological) parameters. This level of care and scientific rigor ensures the safe, topical use of ALLERSPRAY-G.
Randomized, double-blind clinical
Clinical trials confirm the high efficacy of ALLERSPRAY-G. In the short term, its usage shows noticeable reduction in nasal congestion & irritation, and normalization of nasal discharge. This leads to an improvement in the overall quality of life. The protective and cleaning processes of ALLERSPRAY-G are exclusively mechanical, without any interactions with the underlying live biological tissue surface.
Publication : Shrivastava & al. A New Class of Polymeric Anti-Allergen Nasal Barrier Film Solution for the Treatment of Allergic Rhinitis. Journal of Allergy, 2017
Voir la publicationTYPE OF TRIAL: Randomized, double-blind clinical trial against placebo | 3 weeks
PATIENTS: N=51 | Test product = 33 ; Comparator = 15
INCLUSION: Positive skin prick test for allergens and positive basophil count (>10 eosinophils/hpf)
Main results :
TOTAL NASAL SYMPTOMS
- 38 % reduction in total nasal symptoms within 1 week
- 58 % reduction in total nasal symptoms within 2 weeks
- 73 % reduction in total nasal symptoms within 3 weeks
TOTAL OCULAR SYMPTOMS
- 38 % reduction in total ocular symptoms within 1 week
- 55 % reduction in total ocular symptoms within 2 weeks
64 % reduction in total ocular symptoms within 3 weeks
OTHER PARAMETERS
- 50 % improvement in RQLQ score (Rhinoconjunctivitis Quality of Life Questionnaire)
- Rescue medicine score : 80 % for placebo group vs 29 % for test group
- Reduction in eosinophil count : 15 % for placebo group vs 68 % for test group
- 68 % reduction of allergic activity within 3 week
| Indication | Filmogen liquid bandage intended for the treatment of allergic rhinitis of various origins. |
| Composition | Filmogenic glycerol, water, association of Camellia sinensis, Curcuma longa, Panax ginseng, Urtica dioica and EO : Citrus limonum ; potassium sorbate, sodium, citric acid. |
| Presentation | Nasal spray 15ml |
| Class | MDD class I | MDR class IIa |
| Direction | Apply 2 sprays in each nostril, 2-3 times a day. |
| Precautions | For topical use only (nasal cavity). Keep out of reach and sight of children. |
| Age | 18+ |
| Storage conditions | Below 25°C |
| Legal manufacturer | VITROBIO (France) |
| Product code | AAG |