Allerspray-kids: medical device for the treatment of allergic rhinitis for children
Specially designed for children, ALLERSPRAY Kids acts quickly and easily against allergic rhinitis. It also protects the nasal mucosa from allergens by acting as a barrier. Clinical results show an improvement in all allergic rhinitis symptoms (nasal and ocular) after just 2 days of treatment.
Treatment of allergy symptoms in children
Understanding the needs of children, we’ve created Allerspray Kids – an osmotic film-forming nasal spray designed specifically for the little ones. Using the same innovative technology as our original Allerspray, Allerspray Kids provides effective relief from the symptoms of allergic rhinitis while being gentle on children’s delicate nasal tissues.
Unique Formulation
Allerspray Kids contains a specially adjusted formula suitable for children. It consists of the base ingredient, glycerol, combined with solagum and natural plant extracts, providing an osmotic, stable, and absorbent film barrier. This gentle yet effective formulation acts as an allergen shield, cleaning the nasal mucosa and offering immediate relief from symptoms.
Mode of action
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.
Why Allerspray Kids
Allergies can seriously impair children’s quality of life, affecting their sleep, concentration and general well-being. Allerspray Kids has been designed to reduce these undesirable effects and alleviate the constant discomfort of allergic rhinitis.
Safe and Gentle
All the ingredients used in Allerspray Kids are food-grade and non-cytotoxic, ensuring safety for your child’s use. It does not have any cellular interaction, and all its effects are topical, meaning it’s not absorbed into the body but works mechanically on the nasal surface.
Effective Relief
Clinical results demonstrate that Allerspray Kids effectively reduces nasal congestion & irritation, helping to normalize nasal discharge in a short period. It offers a quick, soothing, and effective solution for children dealing with the distress of allergic rhinitis.
Safety & Efficacy
Allerspray Kids meets the Medical Device regulations, and all studies conducted prove its total safety and exclusively topical mode of action. Help your child breathe easier and enjoy their day with Allerspray Kids.
Understanding Pediatric Allergic Rhinitis
Allergic rhinitis (AR) represents a global health problem, affecting a substantial proportion of the pediatric population worldwide. It is an immunoglobulin E (IgE)-mediated inflammation of the nasal passages, typically triggered by airborne allergens.
Prevalence and Impact
Estimates suggest that AR affects 10% to 40% of children worldwide, making it one of the most common chronic diseases in the pediatric population. It has a considerable impact on the quality of life of affected children and their families, interfering with sleep, school performance, and overall daily activities.
Symptoms and Diagnosis
The symptoms of pediatric AR include sneezing, itching, nasal congestion, and clear nasal discharge. Diagnosis is typically based on a combination of a detailed medical history, physical examination, and, if necessary, specific allergy tests.
Treatment Challenges
Treatment of pediatric AR can pose unique challenges. Children may have difficulty tolerating certain treatment methods or may struggle with the proper use of medical devices. Moreover, the potential for systemic side effects and the need for long-term or frequent treatments make safety and tolerability key factors to consider when selecting a treatment option for pediatric AR.
The Need for Innovative Solutions
Given the prevalence and impact of AR in children, there is a need for effective, safe, and easy-to-use treatments. The development of innovative, child-friendly products that address the unique challenges of pediatric AR treatment is of high importance. Such solutions should prioritize safety, ease of use, and patient compliance while effectively addressing the symptoms and root causes of AR.
The Role of Allerspray Kids
The development of Allerspray Kids represents an important advancement in the field of pediatric AR treatment. This mechanical, non-invasive product helps to manage the symptoms of allergic rhinitis by creating an osmotic, stable, and absorbent film on the nasal mucosa, providing an instant protective barrier against environmental allergens. With its specifically designed formulation and mechanism of action, Allerspray Kids addresses the unique challenges of pediatric AR, offering a promising solution to improve the quality of life for affected children.
CLAIMS IN LINE WITH THE NEW REGULATION
- Mechanical mode of action
- Instant osmotic action
- Hydrates, protects and cleanses
- Protects the nasal mucosa against allergens
- Dual action: Relieves and protects
- Significative reduction of allergic symptoms
- Reduces nasal symptoms : congestion, rhinorrhea, sneezing, itching
- Reduces ocular symptoms : itching, tearing, redness
- Reduces the need for medication
- Improves quality of life
- No drowsiness (compared to the placebo group)
- Non-addictive
CLINICAL TRIAL
General informations
Title : An Instant, Safe, Antihistamine, Anti-Inflammatory and Decongestant Polymeric Nasal Barrier to Prevent and To Treat Allergic Rhinitis in Children
Journal : Clinical Research and Clinical Trials | 2021
TYPE OF TRIAL: Randomized, double-blind clinical trial against placebo | 2 weeks
PATIENTS: N=30 | Test product = 20 ; Comparator = 10
INCLUSION: Positive skin prick test for allergens and positive basophil count (>10 eosinophils/hpf)
Link to the publication
MAIN RESULTS
TOTAL NASAL SYMPTOMS
- 36,46 % reduction in total nasal symptoms within 2 days.
- 75,56 % reduction in total nasal symptoms within 7 days.
- 96,24 % reduction in total nasal symptoms within 15 days.
TOTAL OCULAR SYMPTOMS
- 35,12 % reduction in ocular symptoms within 2 days.
- 75,21 % reduction in ocular symptoms within 7 days.
- 99,58 % reduction in ocular symptoms within 15 days
OTHER PARAMETERS
- 73,24 % reduction in rhinorrhea within 7 days.
- 66,67 % reduction in sneezing within 7 days.
| Indication | Filmogen liquid bandage for the treatment of allergic rhinitis in children. |
| Composition | Filmogenic glycerol, solagum, water, association of Vaccinium myrtillus, Curcuma longa and Panax ginseng. Conservatives : Potassium -Sodium - Acid citric. |
| 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). |
| Age | 3+ |
| Storage conditions | Below 25°C |
| Legal manufacturer | VITROBIO (France) |
| Product code | AEE |