drugset / Trial / NCT07543315

Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure

NCT07543315 ↗

Phase 3 Completed 70 enrolled Tanta University
RandomizedParallel-groupTriple-blindTreatment

Summary

The goal of this clinical trial is to evaluate the efficacy of botulinum toxin injection in treatment of patients with chronic anal fissures comparing between two doses of botulinum toxin injection focusing on healing rate, fissure pain, incontinence and return to daily activity. patients will be divided into two groups group A) will receive 50IU from Botulinium toxin type A in the form of two injections at 3 o'clock and 9 o'clock without any anasthesia. While group B) will receive low dose injection in the form of 20IU by the same technique.

Timeline

Start
2023-08-01
Primary completion
2025-08-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 20 iu —
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu —