Article: SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch.
2022 Volume 9, Page(s) 890883
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, ... ...
| 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. |
|---|---|
| Language | English |
| Publishing date | 2022-09-14 |
| Publishing country | Switzerland |
| Document type | Case Reports |
| ZDB-ID | 2775999-4 |
| ISSN | 2296-858X |
| ISSN | 2296-858X |
| DOI | 10.3389/fmed.2022.890883 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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