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

NCT05616455 | Completed Phase 4 DMC

• 1 other identifier: EMOR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fissure Chronic; Anal Fissure

Outcome Measures

Primary Outcomes (1)

• REALISE score

  REALISE (scoRing systEm for AnaL fIsSurE), was used to assess pain (minimum score = 0, maximum score = 10)

  From baseline to visit 3 (40 days after the start of the treatment)

Secondary Outcomes (7)

• Burning

  From baseline to visit 3 (40 days after the start of the treatment)

• Itching

  From baseline to visit 3 (40 days after the start of the treatment)

• Epithelialization

  From baseline to visit 3 (40 days after the start of the treatment)

• Physical and mental health

  From baseline to visit 3 (40 days after the start of the treatment)

• Physical and mental health

  At visit 3 (40 days after the start of the treatment)

Study Arms (2)

Propionibacterium extract gel

EXPERIMENTAL

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.

Drug: Propionibacterium Acnes

0.4% glyceryl trinitrate ointment

ACTIVE COMPARATOR

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.

Drug: glyceryl trinitrate

Interventions

Propionibacterium Acnes DRUG

Application of the gel every 12 hours for 40 days

Propionibacterium extract gel

glyceryl trinitrate DRUG

Application of the gel every 12 hours for 40 days

0.4% glyceryl trinitrate ointment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Treviso Regional Hospital: lead

Study Sites (1)

Regional Hospital Treviso

Treviso, 31100, Italy

Location

MeSH Terms

Conditions

Fissure in Ano

Interventions

chloropentaamminerhodium(III); Nitroglycerin

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 15, 2022
• Study Start: October 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)