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Botox injection study aims to heal painful anal fissures

NCT ID NCT07543315

Disease control Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This completed Phase 3 trial tested two doses of Botox (20 vs 50 units) injected into the anal sphincter to treat chronic anal fissures in 70 adults. The goal was to see which dose better heals the fissure, reduces pain, and allows a quicker return to daily activities. Researchers followed participants for one year to check healing and side effects like incontinence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin type A (Botox)
What this could lead to
If successful, this could help doctors choose the best dose of Botox to heal chronic anal fissures and reduce pain with fewer side effects.
What could go wrong
This is a small, completed trial with only 70 participants, so results may not apply to everyone. Botox injections can cause temporary incontinence or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

150 people

The number who actually took part.

Started

Aug 2023

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants were required to have persistent symptoms despite standard first-line management. Exclusion Criteria: Exclusion criteria included atypical fissure location or appearance, such as lateral or multiple fissures; suspected secondary causes, including Crohn's disease, infection, tuberculosis, HIV-related ulceration, or malignancy; the presence of a perianal fistula or abscess; and contraindications or high-risk conditions for botulinum toxin treatment, including pregnancy, breastfeeding, known hypersensitivity to botulinum toxin products, active infection at the injection site, or significant neuromuscular junction disorders. \-

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic anal fissure

Contacts and locations

Locations

  • Faculty of Medicine Tanta University

    Tanta, Egypt

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