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

Primary Purpose

Anal Fissure Chronic, Anal Fissure

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Propionibacterium Acnes
glyceryl trinitrate
Sponsored by
Treviso Regional Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fissure Chronic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept 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

Sites / Locations

  • Regional Hospital Treviso

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propionibacterium extract gel

0.4% glyceryl trinitrate ointment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Burning
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Itching
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
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.
Physical and mental health
Short-Form 12 (SF-12)
Physical and mental health
SF-36 - Physical component score (PCS)
Physical and mental health
SF-36 - Mental component score (MCS)
Patients' satisfaction
VAS (1 = unsatisfied; 2 = neutral; 3 = quite satisfied; 4 = very satisfied; 5 = extremely satisfied)

Full Information

First Posted
November 5, 2022
Last Updated
November 13, 2022
Sponsor
Treviso Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05616455
Brief Title
Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial
Official Title
Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treviso Regional Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fissure Chronic, Anal Fissure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propionibacterium extract gel
Arm Type
Experimental
Arm 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.
Arm Title
0.4% glyceryl trinitrate ointment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Propionibacterium Acnes
Intervention Description
Application of the gel every 12 hours for 40 days
Intervention Type
Drug
Intervention Name(s)
glyceryl trinitrate
Intervention Description
Application of the gel every 12 hours for 40 days
Primary Outcome Measure Information:
Title
REALISE score
Description
REALISE (scoRing systEm for AnaL fIsSurE), was used to assess pain (minimum score = 0, maximum score = 10)
Time Frame
From baseline to visit 3 (40 days after the start of the treatment)
Secondary Outcome Measure Information:
Title
Burning
Description
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Time Frame
From baseline to visit 3 (40 days after the start of the treatment)
Title
Itching
Description
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Time Frame
From baseline to visit 3 (40 days after the start of the treatment)
Title
Epithelialization
Description
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.
Time Frame
From baseline to visit 3 (40 days after the start of the treatment)
Title
Physical and mental health
Description
Short-Form 12 (SF-12)
Time Frame
From baseline to visit 3 (40 days after the start of the treatment)
Title
Physical and mental health
Description
SF-36 - Physical component score (PCS)
Time Frame
At visit 3 (40 days after the start of the treatment)
Title
Physical and mental health
Description
SF-36 - Mental component score (MCS)
Time Frame
At visit 3 (40 days after the start of the treatment)
Title
Patients' satisfaction
Description
VAS (1 = unsatisfied; 2 = neutral; 3 = quite satisfied; 4 = very satisfied; 5 = extremely satisfied)
Time Frame
At visit 3 (40 days after the start of the treatment)

10. Eligibility

Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Regional Hospital Treviso
City
Treviso
ZIP/Postal Code
31100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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