Class IIa Medical Device
(1) 30-ml spray for topical application on external hemorrhoids &
(2) 10-ml tube for internal hemorrhoids.
Piles & Hemorrhoids
Physiopathology: The anal area is highly vascularized & fragile. Any initial
injury leads to the exposure of blood vessels, arrival of inflammatory cells,
liberation of anti & pro inflammatory cytokines, & protrusion of blood
vessels. Due to strain, inflammation continues, the amount of pro
inflammatory cytokines exceeds anti-inflammatory cytokines, inflamed
vessels swell, & piles generate at the anal opening level. Inflammatory
cascade continues for years & dilated vessels cause pain & itching.
Ideal Treatment Approach: An effective treatment must be topical to avoid side effects, safe, non-irritant, with 4 main effects on the lesion:
3. Neutralize mainly pro-inflammatory cytokines
4. Reduce oedema, pain & irritation.
Currently Available Treatments:
• As the pro-inflammatory cytokines are not identified, there are only symptomatic treatments.
• All the currently available treatments such as: anti-inflammatory drugs, antiseptics, saline solutions, oral venotonics & corticosteroids, oral flavonoids, sclerotherapy, rubber band legation, infrared coagulation, radiofrequency ablation, & cryotherapy are symptomatic, painful, tissue-damaging, long lasting & expensive. In fact, there is no specific treatment.
VITROBIO‘s Completely NEW Therapeutic Approach: For the last 17 years, Vitrobio has been conducting R&D to conceive a topical treatment for hemorrhoids capable of instantly cleaning & hydrating; neutralizing specifically the pro-inflammatory cytokines; inducing exudation of liquid from the dilated blood vessels so as to reduce their volume & allow them to resume their normal physiology & functions; and reducing pain, irritation, itching & bleeding.
Vitrobio discovered & patented (Patents: PCT/FR99/01340 in 1997 & N° WO 00/74668 A1 in 2000) a strongly hypertonic yet nonirritant solution (VB-Gy) so as to induce exudation of fluid from the dilated blood vessels & to keep the lesion hydrated. 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) present on the injured surfaces in different pathologies (ex. piles) and neutralized these proteins using specific Polymers (Patents PCT/EP2008/064214, Int. N° WO 2010/045969 A1 in 2008).
These polymers were then introduced in VB-Gy to conceive a new generation of topical treatment for piles & hemorrhoids in 2012.
Product Presentation: External hemorrhoids: 30 ml spray. Internal hemorrhoids: A concentrated solution in 50 ml tube.
Posology: Topical spray on the external lesions (3-4 sprays 4-5 times/day) or a 0.5-1 ml on internal piles, twice a day.
Regulatory Status: Due to the mechanical & topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structures, these products are classified as Class IIa Medical Device in Europe.
Contraindications: None (over 8 years of age).
Side Effects: Slight local irritation during the first 1-2 minutes after each application.
Conclusion: Pileseptine is a multifactorial & highly effective new class of treatment for Piles & hemorrhoids