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

Felemovicius, Isaac / Ganz, Robert A / Saremi, Mohammad / Christopfel, William

Frontiers in medicine

2022  Band 9, Seite(n) 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.
Sprache Englisch
Erscheinungsdatum 2022-09-14
Erscheinungsland Switzerland
Dokumenttyp Case Reports
ZDB-ID 2775999-4
ISSN 2296-858X
ISSN 2296-858X
DOI 10.3389/fmed.2022.890883
Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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