Phase 3 Trial: 50IU vs 20IU OnabotulinumtoxinA for Chronic Anal Fissure
Summary
NIH has registered a Phase 3 clinical trial (NCT07543315) evaluating the efficacy of botulinum toxin type A injection for chronic anal fissure treatment, comparing a high dose of 50IU versus a low dose of 20IU. The trial will assess healing rates, fissure pain, incontinence, and return to daily activity as primary outcomes. Patients will be divided into two groups receiving the respective doses via the same injection technique.
“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.”
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What changed
NIH has registered a new Phase 3 clinical trial on ClinicalTrials.gov, designated NCT07543315. The trial will evaluate two dosing regimens of botulinum toxin type A for chronic anal fissure: Group A receives 50IU via two injections at the 3 o'clock and 9 o'clock positions, while Group B receives 20IU using the same technique. No anesthesia is used for either group.
Healthcare providers and clinical investigators should note that this trial represents a head-to-head dose-comparison study for a common anorectal condition. Trial sponsors conducting similar gastroenterology or anorectal studies should monitor enrollment criteria and outcome measures for potential alignment with ongoing or planned programs.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure
Phase 3 NCT07543315 Kind: PHASE3 Apr 21, 2026
Abstract
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: injection of Botulinum type A
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