1st topical filmogen medical device to mechanically reduce simultaneously hemorrhoidal volume, inflammation, irritation & itching
– Class IIa Medical Device – External hemorrhoids: 30-ml liquid spray
– Internal hemorrhoids: 50-ml tube containing gel
Registered as Medical Device (2017 – LNE-Gmed France)
Piles & Hemorrhoids
Physiopathology: The anal area is highly vascularized & fragile. An injury may lead to the protrusion of a strangulated blood vessel. Arteries being more elastic compared to the veins, liquid starts accumulating progressively in the lesion. Continuous dilation leads to the formation of an edematous mass & surface inflammation. In the absence of lesion regression, anti-inflammatory cytokines are replaced by pro-inflammatory cytokines & lesion becomes chronic. Only removing edema & inflammation may help recovery.
An ideal treatment:
An effective treatment must be topical to avoid side effects, safe, non-irritant, with 4 main effects on the lesion:
- Neutralize mainly pro-inflammatory cytokines &
- Reduce oedema, pain & irritation
Currently Available Treatments:
- There is no non-irritant & strong topical anti-edematous drug yet discovered.
- 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 multifactorial 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 the lesion; mechanically remove the pro-inflammatory cytokines from the hemorrhoidal surface to stop inflammation; inducing exudation of liquid from the dilated blood vessels so as to reduce their volume & allow them to resume their normal physiology & functions; thereby 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 non-irritant 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.
VITROBIO used its patented filmogen osmotic VB-Gy solution to conceive a new generation of topical treatment for piles & hemorrhoids capable of reducing the size of the piles, keeping the lesion surface hydrated continuously, and cleaning the hemorrhoid surface to help reduce/stop inflammation & pain – all at once.
Posology: Topical spray on the external lesions (3-4 sprays, 3-4 times/day). Class IIa Medical Device in EU. Totally safe.
Pilot clinical trial 1: Placebo 20 Hypertonic saline treated & 31 Pileseptine treated patients (60 days).
Clinical trial 2: 51Patient (Pileseptine “VB-Pile” n=31, placebo n=20), single-blind, multicenter, 6-week trial. New trials ongoing.
RESULTS: Differences compared to the hypertonic solution-treated placebo group: Rectal pain (-47.69%); Bleeding (-59.21%); Rectal pruritus (-72.63%); Rectal prolapse (-31.47%); Constipation (-18.18%); Weakness (-63.81%); Rectal growth (-81.19%)
Publications: (1) Georges M et al. J Clin Exp Dermatol Res. 2017; 8: 403. doi:10.4172/2155-9554.1000403. (2) Shrivastava et al. J Clin & Expt Pharmacol. 2018, 8:1. (3) Gisela Da Silva et al. 2018. J Clinical Trials & Res. JCTR, 1(1): 5-7.
Conclusion: Pileseptine is the 1st topical mechanical (cleaning away contaminants and inflammatory particles from the hemorrhoidal surface, attracting stagnant liquid to reduce oedema, protecting and hydrating the tissue to soothe irritation) treatment for internal (gel) & external (spray) hemorrhoids.