1st topical filmogen medical device to 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:

  1. Clean
  2. Hydrate
  3. Neutralize mainly pro-inflammatory cytokines &
  4. 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 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; 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; 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.

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 capable to reduce the size of the piles, keep the lesion surface hydrated continuously, and 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.


Clinical Efficacy:  

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 anti-edematous & mechanical anti-inflammatory drug for the treatment of internal (gel) & external (spray) hemorrhoids.