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Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure

NCT07543315 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Chronic Anal Fissure

Interventions

DRUG

injection of Botulinum type A

injection of low dose 20 IU of Botoulinum toxin type A to arm 1 and high dose 50 IU to arm 2

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-08-30
Completion
2026-08-30
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543315 on ClinicalTrials.gov