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Class IIa Medical Device: 30 ml spray for topical application on the skin lesions of allergic dermatitis

Physiopathology: Dermatitis occurs when chemicals or physical agents damage the surface of the skin faster than the skin is able to repair the damage. Irritants remove oils and moisture from the skin’s outer layer, allowing chemical irritants to penetrate more deeply and cause further damage by triggering inflammation.
Irritant & Allergic contact dermatitis is now getting as common as Rhinitis! This is due to excessive pollution on one hand, liberating many chemicals in the atmosphere & the over-cleanliness of modern human population, on the other hand. An inexperienced immune system considers a common substance as “foreign”, immune T cells keep this in memory & launch a strong terrorist attack each time the presumably foreign substance comes in contact with the dermis. They produce histamines & launch a cytokine inflammatory cascade leading to the up-regulation of certain pro-inflammatory cytokines. Each time the skin comes in contact with the antigen, the whole process starts again, causing local inflammation, itching, irritation, swelling, pain, & cellular destruction.

An ideal treatment: Should remove T cell memory or stop exaggerated immune reaction to non-pathogenic antigens, or normalize the immune system, BUT the immune-modulatory mechanisms are too complex and any such treatment would destroy the whole immune system in the body with multiple side effects. Therefore, treatment must be topical. A good treatment should at least clean the lesion, minimize the topical concentration of pro-inflammatory cytokines, repair cellular damage & relieve clinical symptoms in the shortest possible time.
Currently available treatments: Corticosteroids, anti-histamines, topical cleaning, soothing & anti-irritant creams & lotions are commonly used but they are usually chemicals with side effects, they acts slowly, and have only symptomatic effects.
New Therapeutic Approach: The aim of Vitrobio research was to develop a topically active hypertonic liquid capable of instantly minimizing the concentration of histamines, pro-inflammatory cytokines, and stimulating the repair of damaged cells.
During initial research, Vitrobio discovered & patented (PCT/FR99/01340 in 1997 & N° WO 00/74668 A1 in 2000) a strongly hypertonic yet non-irritant solution (VB-Gy) so as to create an outward exudation of hypotonic liquid from the lesion and to drain the histamine, cytokines and dead cells from the lesion. This solution was further rendered filmogen (PCT/EP2013/061835 in 2013) for a long lasting (5-6h) effect.
Employing in vitro technology (European PAEXA & French Academy of Science Awards), Vitrobio identified pro-inflammatory cytokines (proteins) involved in allergic reactions which are known to maintain inflammation and cause cellular damage. These cytokines were then neutralized using specific Polymers (Patents PCT/EP2008/064214, Int. N° WO 2010/045969 A1 in 2008).
We also found that certain polyunsaturated fatty acids are essential to maintain the integrity of cellular matrix and to regenerate cell membrane. These polymers and fatty acids were then introduced in VB-Gy to conceive a new generation of topical treatment for the lesions of dermatitis.
Product Presentation: 30 ml aluminum spray containing 100-120 sprays for topical application.
Posology: Topical spray on the lesions, 3-4 times per day up to complete recovery.
Regulatory Status: Due to the mechanical & topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structures, this product is classified as Class IIa Medical Device in Europe.
Contraindications: None.
Side Effects: Slight local irritation on open lesions, none on the intact skin.
Clinical Efficacy: Under preparation (May – June 2015).

Conclusion: Theoretically, Derm-ALLERSPRAY is a very promising medical device to treat skin allergic lesions but the claims must be proven clinically.