Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial

NCT ID: NCT05616455

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-05-31

Brief Summary

The study compares the efficacy and safety of a Propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.

Detailed Description

Patients were randomly allocated to a PeG or GTN group and medication was taken every 12 hours for 40 days. Primary outcome was the success rate as measured by a decrease in the REALISE score at 10, 20 and 40 days after starting either treatment. The secondary out-comes were the healing rate, the partial or complete resolution of itching and burning, the rate of complications and adverse events, patients' quality of life and satisfaction at the same time points.

Conditions

Anal Fissure Chronic; Anal Fissure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Propionibacterium extract gel

The Propionibacterium extract gel is a topical product that protect the skin and mucous membranes from external agents. Its film forming property on the epidermis helps reduce inflammation, itching and pain, while the adjunct of antioxidant ingredients helps promote the healing process.

Patients were instructed to squeeze out from the aluminium tubes containing the Propionibacterium extract gel, 3 grams of gel (3 cm), applying it twice a day for 40 days in the distal anal canal and perianal area.

Group Type: EXPERIMENTAL

Propionibacterium Acnes

Intervention Type: DRUG

Application of the gel every 12 hours for 40 days

0.4% glyceryl trinitrate ointment

0.4% glyceryl trinitrate ointment is a well-known nitric oxide donor which promotes fissure healing by decreasing resting anal pressure and increasing anoderm blood flow, via the stimulation of the intracellular cyclic GMP resulting in a consequent reduction in cytosolic calcium. The success rate is variable, with 28% of patients experiencing transient headache often leading to drug discontinuation and poor compliance to treatment.

Patients were instructed to squeeze out from the aluminium tubes containing 0.4% glyceryl trinitrate ointment approximately 1.5 mg of the ointment applying it to the distal anal canal and perianal area with a gloved finger, every 12 hours for 40 days.

Group Type: ACTIVE_COMPARATOR

glyceryl trinitrate

Intervention Type: DRUG

Application of the gel every 12 hours for 40 days

Interventions

Propionibacterium Acnes

Application of the gel every 12 hours for 40 days

Intervention Type: DRUG

glyceryl trinitrate

Application of the gel every 12 hours for 40 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years

Exclusion Criteria

• Fecal incontinence
• Inflammatory bowel disease
• Previous history of anal surgery
• Previous or concomitant treatment for anal fissure, sexually transmitted disease, cancer, immune-suppressive treatment
• Current pregnancy or breastfeeding
• Known allergy to one of the agents contained into the evaluating drugs

• Accepts Healthy Volunteers: No

Sponsors

Treviso Regional Hospital

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Regional Hospital Treviso

Treviso, , Italy

Countries

Italy

Other Identifiers

EMOR

Identifier Type: -

Identifier Source: org_study_id