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Warning: The information provided on this page is for general knowledge purposes only and does not replace the official Instructions for Use (IFU), which are supplied with the medical device. This page does not constitute an electronic IFU either.

PILESEPTINE : treatment for hemorrhoids

PILESEPTINE is a Class IIa medical device designed as a filmogen liquid bandage for the treatment of hemorrhoids. The gel provides a protective barrier, osmotic cleaning, and promotes cellular repair. Clinical trials have shown significant improvements in symptoms such as pain intensity, rectal bleeding, prolapse extent, defecation discomfort, and irritation after defecation, with noticeable results appearing as early as 2 days into the treatment.

Available in 50ml gel tube and 30ml spray version

Clinical trial

Randomized, double-blind, placebo-controlled trial

Population

This product is intended for adult use

Indication

Treatment of external hemorrhoids

Patient's benefits

Relieves pain associated with hemorrhoids
Reduces rectal bleeding
Decreases prolapse extent
Improves defecation comfort
Soothes post-defecation irritation from the first days of treatment
Provides rapid relief, with measurable improvements as early as day 2
Well tolerated, with no side effects reported during the clinical study
Safe and effective topical solution for internal hemorrhoid management

Mode of action

PILESEPTINE targets pro-inflammatory proteins, contaminants, and impurities, providing a comprehensive approach to hemorrhoid treatment.

Protective Barrier Effect: The gel acts as a protective barrier, shielding the inflamed area from further irritation and damage. This barrier also helps to prevent the adhesion of contaminants and impurities that can exacerbate inflammation and discomfort.

Osmotic and Cleaning Effect: The high osmotic activity of the gel instantly attracts and traps most of the adhered contaminants, including inflammatory proteins. This action helps to suppress inflammation and the immune cascade, providing immediate relief from discomfort.

Cellular Repair and Growth Effect: Once the biological surface is clean and hydrated, cell growth and healing are immediately triggered. This promotes the repair of the damaged tissue, further alleviating the symptoms of hemorrhoids.

Available in 50ml gel tube and 30ml spray version
Each version of the product has its own clinical study. The gel version is presented here.

Clinical Trial

PILESEPTINE GEL demonstrated strong clinical efficacy and safety in a randomized, double-blind, placebo-controlled trial involving 54 patients with internal hemorrhoids.

Over a 14-day treatment period, the gel led to a 51% reduction in pain intensity, a 49% reduction in rectal bleeding, and a 27% decrease in prolapse extent. Defecation discomfort improved by nearly 70%, and irritation after defecation was significantly reduced.

Improvements were observed as early as 2–3 days into treatment and continued progressively. The product was well tolerated, with no adverse effects reported, confirming PILESEPTINE GEL as a safe and effective option for symptom relief and healing in patients with internal hemorrhoids.

Product Details

Indication: Filmogen liquid bandage for the treatment of external hemorrhoids (piles).
Composition: Active ingredients* of natural origin.
Presentation: Tube 50ml or spray 30ml - Class IIa.
Class: Current certification: MDD Class IIa.
Age: 18+.
Storage conditions: Below 25°C.
Legal manufacturer: VITROBIO (France).
Product code: PII (gel) PIE (spray).