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

Treviso Regional Hospital

Status and phase: Completed; Phase 4

Conditions: Anal Fissure Chronic; Anal Fissure

Treatments: Drug: Propionibacterium Acnes; Drug: glyceryl trinitrate

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05616455

EMOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Propionibacterium extract gel

Experimental group

Description:

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.

Treatment:

Drug: Propionibacterium Acnes

0.4% glyceryl trinitrate ointment

Active Comparator group

Description:

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.

Treatment:

Drug: glyceryl trinitrate