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New treatment option for Fissure in Ano
Official title Complex Treatment of a Chronic Anal Fissure
ClinicalTrials.gov ID: NCT03855046
What this study is testing
What is IncobotulinumtoxinA 50 U Intramuscular Powder for Solution?
IncobotulinumtoxinA 50 U Intramuscular Powder for Solution is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for fissure in ano.
Also referred to as Xeomin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients with chronic anal fissure
You likely can't join if
- Inflammatory diseases of the colon
- Pectenosis
- Previous surgical interventions on the anal canal
- IV grade internal and external hemorrhoids
- Rectal fistula
- Severe somatic diseases at the decompensation stage
See the full eligibility criteria
- Patients with chronic anal fissure
- Inflammatory diseases of the colon
- Pectenosis
- Previous surgical interventions on the anal canal
- IV grade internal and external hemorrhoids
- Rectal fistula
- Severe somatic diseases at the decompensation stage
- Pregnancy and lactation
- Individual intolerance and hypersensitivity to botulinum toxin
- Myasthenia gravis and myasthenia-like syndromes
- Anal sphincter insufficiency
The study team makes the final eligibility decision.
Where it's taking place
- Podolsk, Moscow Oblast, Russia
- Astrakhan, Russia
- Moscow, Russia
- Saint Petersburg, Russia
- Tomsk, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Podolsk, Moscow Oblast, Russia; Astrakhan, Russia; Moscow, Russia; Saint Petersburg, Russia; Tomsk, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.