NCT05616455

Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Treviso Regional Hospital · Network
• Sex: —
• Age: —
• Healthy volunteers: Not accepted

Summary

The study compares the efficacy and safety of a Propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.

Detailed description

Patients were randomly allocated to a PeG or GTN group and medication was taken every 12 hours for 40 days. Primary outcome was the success rate as measured by a decrease in the REALISE score at 10, 20 and 40 days after starting either treatment. The secondary out-comes were the healing rate, the partial or complete resolution of itching and burning, the rate of complications and adverse events, patients' quality of life and satisfaction at the same time points.

Conditions

• Anal Fissure Chronic
• Anal Fissure

Interventions

Type	Name	Description
DRUG	Propionibacterium Acnes	Application of the gel every 12 hours for 40 days
DRUG	glyceryl trinitrate	Application of the gel every 12 hours for 40 days

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-03-31
• Completion: 2022-05-31
• First posted: 2022-11-15
• Last updated: 2022-11-15

Locations

1 site across 1 country: Italy