Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID04153032

Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure: a Randomized Clinical Trial

Led by American University of Beirut Medical Center · Updated on 2025-01-29

183

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating topical treatments for acute anal fissure by comparing MEBO ointment, topical diltiazem (DTZ) ointment, and a combination of both. This randomized controlled trial aims to determine which treatment is more effective and safe, with the hypothesis that the combination of MEBO and DTZ may work better than either ointment alone. The study is designed as a phase 2 trial with a parallel group design and multiple assessment points. Participants will be randomly assigned to one of three groups: applying MEBO ointment, DTZ ointment, or a combination of both, each applied peri-anally three times daily for six weeks. Those who do not improve after two weeks on either MEBO or DTZ alone may switch to the combination treatment, and if they still do not improve, surgery may be offered. Treatment allocation is concealed until after consent, and the patient and physician will know the treatment, while other study personnel remain blinded. Participants will be evaluated at weeks 1, 6, and 10 after starting treatment. Assessments include pain scores, wound healing, strain during defecation, and the patient's overall impression of improvement. Patients will keep diaries recording pain and strain scores for three days before each follow-up. Safety and adverse events are monitored throughout, and data will be analyzed to compare the treatments. The total study duration per participant includes these visits and follow-ups over about 10 weeks.

CONDITIONS

Brief Title

Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must be 18 years and above.
  • Subjects with 3 months (90 days) or less history of painful anal fissure.
  • Subjects experiencing anal fissure-related pain at least twice a week during symptoms.
  • Pain scores averaging 3 or higher on an 11-point scale during symptomatic phase.
  • Average pain score of 4 or higher on an 11-point scale during screening for the most recent 3 days with defecation.
  • Evidence of a radial fissure with hardened edges seen on anal exam.
  • Willing to stop all other topical treatments applied around the anus before and during the study.
  • Able to give informed consent.
Not Eligible

You will not qualify if you...

  • Unwillingness to undergo anal fissure examination.
  • Previous lateral sphincterotomy, anal stretch, or other surgeries involving the anal or perianal region.
  • History of perianal abscess incision.
  • Botulinum toxin injection in the anal area within 6 months prior to screening.
  • Use of glyceryl trinitrate ointment for more than 1 week within 4 weeks before screening.
  • Anal fissure caused by other conditions such as drug effects, trauma, HIV, fistula, inflammatory bowel disease, infection, or cancer.
  • Cardiovascular disease.
  • Known allergy to diltiazem or ingredients in MEBO ointment (sesame oil).
  • Use of prohibited medications or experimental agents within a specified time before screening.
  • Gastrointestinal disorders like inflammatory bowel disease, chronic fecal incontinence, radiation therapy to the pelvis, or fixed anal stenosis/fibrosis.
  • Major psychiatric or blood disorders, including substance abuse.
  • Scheduled elective or other hospital treatments during the study.
  • Likely to be unavailable, noncompliant, or unsuitable for study participation.
  • Taking oral therapy for anal fissure.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants apply MEBO ointment, topical Diltiazem ointment, or a combination of both peri-anally 3 times daily for 6 weeks. Those who do not improve after 2 weeks on either MEBO or Diltiazem may switch to the combination treatment or proceed to surgery if needed.

2 visits at weeks 1 and 6 (in-person)

Follow-up

Duration - 4 weeks after treatment

Participants are assessed for pain, wound healing, defecation strain, and global impression of improvement at 10 weeks from the study start date.

1 visit at week 10 (in-person)

Trial Site Locations

Total: 1 location

1

American University of Beirut

Beirut, Lebanon

Actively Recruiting

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Research Team

E

Eman Sbaity, MD

M

Mohamad Hadi El Charif, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Frequently Asked Questions

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Published Research Related To This Trial

Internal anal sphincter function following lateral internal sphincterotomy for anal fissure: a long-term manometric study.

Edward Ram, Dan Alper, Gideon Y Stein...

https://pubmed.ncbi.nlm.nih.gov/16041211

Moist Exposed Burn Ointment (MEBO) in partial thickness burns - a randomized, comparative open mono-center study on the efficacy of dermaheal (MEBO) ointment on thermal 2nd degree burns compared to conventional therapy.

T Hirsch, W Ashkar, O Schumacher...

https://pubmed.ncbi.nlm.nih.gov/19073386

The role of alternative therapy in the management of partial thickness burns of the face--experience with the use of moist exposed burn ointment (MEBO) compared with silver sulphadiazine.

E S Ang, S T Lee, C S Gan...

https://pubmed.ncbi.nlm.nih.gov/10748957