Dataset Information

SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch.

ABSTRACT:

Introduction

Pruritus ani, or rectal or anal itch, is a common perianal disorder that affects ~5% of the population of the developed world. Treatments for this disorder are somewhat limited and include conservative non-medical perianal hygiene care, and topical medical treatments including topical steroids, antibacterial and antifungal agents, and topical anesthetic/analgesics such as lidocaine or capsaicin; astringents and vasoconstrictors such as ephedrine can also be used.

Methods

The study was IRB approved. We assessed the efficacy of a novel, composite, over-the-counter, topical lidocaine ointment that included an epidermal barrier and antimicrobial effect along with the typical lidocaine anesthetizing effect, in a single arm, observational, longitudinal, population of 20 ambulatory pruritus ani patients. Patients applied the ointment twice daily, and were studied for 2 weeks; primary outcomes included time to symptom resolution and clinical exam resolution as measured on a 5-point visual analog scale.

Results

Twenty-nine consecutive patients were screened and 20 patients (12 males; 8 females) were enrolled in the study. Ninety percent of patients achieved 100% symptom resolution by 2 weeks, and most were improved within 72 h of initiating treatment; 95% of patients had a normal visual exam by the 2 week endpoint. There were no significant adverse events attributable to the therapy.

Conclusion

Use of a novel composite topical lidocaine agent, demonstrated rapid and effective relief of pruritus ani in an ambulatory population. Additional studies are underway.

Clinical trial registered

Clinicaltrials.gov, identifier NCT05288907.

SUBMITTER: Felemovicius I

PROVIDER: S-EPMC9515464 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch.

Felemovicius Isaac I Ganz Robert A RA Saremi Mohammad M Christopfel William W

Frontiers in medicine 20220914

<h4>Introduction</h4>Pruritus ani, or rectal or anal itch, is a common perianal disorder that affects ~5% of the population of the developed world. Treatments for this disorder are somewhat limited and include conservative non-medical perianal hygiene care, and topical medical treatments including topical steroids, antibacterial and antifungal agents, and topical anesthetic/analgesics such as lidocaine or capsaicin; astringents and vasoconstrictors such as ephedrine can also be used.<h4>Methods< ...[more]

PMID: 36186810

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Dataset Information

SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch.

Introduction

Methods

Results

Conclusion

Clinical trial registered

Publications

SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch.

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