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

Anal Fissure Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616455
• Other study ID #: EMOR
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2022
• Source: Treviso Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Fissure
• Anal Fissure Chronic
• Fissure in Ano

Intervention

Drug:
• Propionibacterium Acnes
Application of the gel every 12 hours for 40 days
• glyceryl trinitrate
Application of the gel every 12 hours for 40 days

Locations

Country	Name	City	State
Italy	Regional Hospital Treviso	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
Treviso Regional Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Burning	Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)	From baseline to visit 3 (40 days after the start of the treatment)
Secondary	Itching	Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)	From baseline to visit 3 (40 days after the start of the treatment)
Secondary	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)
Secondary	Physical and mental health	Short-Form 12 (SF-12)	From baseline to visit 3 (40 days after the start of the treatment)
Secondary	Physical and mental health	SF-36 - Physical component score (PCS)	At visit 3 (40 days after the start of the treatment)
Secondary	Physical and mental health	SF-36 - Mental component score (MCS)	At visit 3 (40 days after the start of the treatment)
Secondary	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)