Anal Fissure ChronicPhase 4NCT05616455
Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial
A Phase 4 study testing Propionibacterium Acnes and glyceryl trinitrate in people with Anal Fissure Chronic and Anal Fissure, run by Treviso Regional Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Fissure Chronic, Anal Fissure
- What is being tested?
- Propionibacterium Acnes and glyceryl trinitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 31 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anal Fissure Chronic, Anal Fissure
- Being tested
- Propionibacterium Acnes, glyceryl trinitrate
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionibacterium AcnesDrug
Application of the gel every 12 hours for 40 days
glyceryl trinitrateDrug
Application of the gel every 12 hours for 40 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: glyceryl trinitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
REALISE score
REALISE (scoRing systEm for AnaL fIsSurE), was used to assess pain (minimum score = 0, maximum score = 10)
Measured: From baseline to visit 3 (40 days after the start of the treatment)
Secondary outcomes (7)
Burning
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Measured: From baseline to visit 3 (40 days after the start of the treatment)
Itching
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Measured: 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.
Measured: From baseline to visit 3 (40 days after the start of the treatment)
Physical and mental health
Short-Form 12 (SF-12)
Measured: From baseline to visit 3 (40 days after the start of the treatment)
Physical and mental health
SF-36 - Physical component score (PCS)
Measured: At visit 3 (40 days after the start of the treatment)
Physical and mental health
SF-36 - Mental component score (MCS)
Measured: 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)
Measured: At visit 3 (40 days after the start of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Oct 2021
- Primary completion31 Mar 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Fissure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treviso Regional Hospital
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616455
- Sponsor's protocol ID
- EMOR
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05616455
- Acronym / sponsor ID
- EMOR
- Conditions
- Anal Fissure Chronic, Anal Fissure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Treviso Regional HospitalResearch network
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propionibacterium extract gel | Experimental | Drug: Propionibacterium AcnesThe 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 | Active comparator | Drug: glyceryl trinitrate0.4% 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. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propionibacterium AcnesApplication of the gel every 12 hours for 40 days | Drug | Propionibacterium extract gel |
| glyceryl trinitrateApplication of the gel every 12 hours for 40 days | Drug | 0.4% glyceryl trinitrate ointment |
Primary outcome
REALISE score
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
REALISE (scoRing systEm for AnaL fIsSurE), was used to assess pain (minimum score = 0, maximum score = 10)
7 secondary outcomes
Burning
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Itching
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Epithelialization
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Physical and mental health
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Physical and mental health
Time frame: At visit 3 (40 days after the start of the treatment)
Physical and mental health
Time frame: At visit 3 (40 days after the start of the treatment)
Patients' satisfaction
Time frame: At visit 3 (40 days after the start of the treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propionibacterium Acnes and glyceryl trinitrate in people with Anal Fissure Chronic and Anal Fissure, run by Treviso Regional Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REALISE score (time frame: From baseline to visit 3 (40 days after the start of the treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.