Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure

NCT07543315 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 36264PR284/7/23
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• pain reduction measured by visual analogue scale

  change in pain score from baseline to follow up visits after botulinum toxin injection

  4 weeks

Secondary Outcomes (1)

• Fissure complete healing

  4-8 weeks

Study Arms (2)

Arm 1 Low Dose Group

EXPERIMENTAL

Patients recieve injection of a low dose 20 IU of botulinum toxin for treatment of chronic anal fissure

Drug: injection of Botulinum type A

Arm2 : High Dose group

EXPERIMENTAL

Patients recieve injection of a high dose 50 IU of botulinum toxin for treatment of chronic anal fissure

Drug: injection of Botulinum type A

Interventions

injection of Botulinum type A DRUG

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

Arm 1 Low Dose Group; Arm2 : High Dose group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were required to have persistent symptoms despite standard first-line management.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine Tanta University

Tanta, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: August 1, 2023
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)