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

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.

Study Overview

• Status: Completed
• Conditions: Anal Fissure; Anal Fissure Chronic
• Intervention / Treatment: Drug: Propionibacterium Acnes; Drug: glyceryl trinitrate

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Treviso, Italy, 31100
    • Regional Hospital Treviso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Propionibacterium Acnes; Application of the gel every 12 hours for 40 days
Active Comparator: 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.	Drug: glyceryl trinitrate; Application of the gel every 12 hours for 40 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burning	Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)	From baseline to visit 3 (40 days after the start of the treatment)
Itching	Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)	From baseline to visit 3 (40 days after the start of the treatment)
Epithelialization	The degree of epithelialization of the fissure was determined at each visit and stratified using 3 levels (1 to 3) corresponding to <50%, >50% of healing or complete healing, respectively.	From baseline to visit 3 (40 days after the start of the treatment)
Physical and mental health	Short-Form 12 (SF-12)	From baseline to visit 3 (40 days after the start of the treatment)
Physical and mental health	SF-36 - Physical component score (PCS)	At visit 3 (40 days after the start of the treatment)
Physical and mental health	SF-36 - Mental component score (MCS)	At visit 3 (40 days after the start of the treatment)
Patients' satisfaction	VAS (1 = unsatisfied; 2 = neutral; 3 = quite satisfied; 4 = very satisfied; 5 = extremely satisfied)	At visit 3 (40 days after the start of the treatment)

Collaborators and Investigators

• Sponsor: Treviso Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Fissure in Ano; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: EMOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No