Overview
Introducing PILESEPTINE GEL, a Class IIa medical device specifically designed to provide relief and treatment for internal hemorrhoids, also known as piles. This innovative product offers a unique three-fold action to alleviate the discomfort and symptoms associated with internal hemorrhoids.
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 internal 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
The effectiveness of PILESEPTINE GEL has been confirmed through a randomized, double-blind, placebo-controlled trial over a period of 2 weeks. The study involved 54 patients, with 36 using the test product and 18 using the comparator.
Key Findings
The main results of the study were as follows:
- Pain intensity was significantly reduced within 14 days.
- Rectal bleeding was notably reduced within the same period.
- The extent of prolapse was reduced within 14 days.
- Defecation discomfort improved within 14 days.
- Irritation after defecation was significantly reduced within 14 days.
These results clearly demonstrate the effectiveness of PILESEPTINE GEL in providing relief and promoting healing in patients suffering from internal hemorrhoids. The product was well-tolerated with no recorded side effects, making it a safe and effective option for hemorrhoid treatment.
Main results
Pain Intensity
• 24 % reduction in pain intensity within 3 days, compare to CP
• 38 % reduction in pain intensity within 8 days, compare to CP
• 51 % reduction in pain intensity within 14 days, compare to CP
Bleeding
• 9 % reduction in rectal bleeding within 2 days, compare to CP
• 22 % reduction in rectal bleeding within 3 days, compare to CP
• 33 % reduction in rectal bleeding within 8 days, compare to CP
• 49 % reduction in rectal bleeding within 14 days, compare to CP
Extend of prolapse
• 5 % reduction in the extend of prolapse within 2 days.
• 13 % reduction in the extend of prolapse within 3 days.
• 22 % reduction in the extend of prolapse within 8 days.
• 27 % reduction in the extend of prolapse within 14 days.
Defecation discomfort
• 18 % improvement in defecation discomfort within 2 days.
• 35,5 % improvement in defecation discomfort within 3 days.
• 52,6 % improvement in defecation discomfort within 8 days.
• 69,7 % improvement in defecation discomfort within 14 days.
Product Details
- Indication: Filmogen liquid bandage for the treatment of internal hemorrhoids (piles).
- Composition (gel): Filmogenic glycerol, water, association of Vaccinium macrocarpon, Vitis vinifera, EO: Mentha piperita, and Linum Usitatissimum oil.
- Composition (spray):Filmogenic glycerol, water, association of Vaccinium macrocarpon, Vitris vinifera, EO : Mentha piperita.
- Presentation: Tube 50ml or spray 30ml - Class IIa.
- Class: Current certification: MDD Class IIa.
- Direction: Apply to wounds, 2-3 times a day.
- Precautions: For topical use only. Keep out of reach and sight of children.
- Age: 18+.
- Storage conditions: Below 25°C.
- Legal manufacturer: VITROBIO (France).
- Product code: PII (gel) PIE (spray).