{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T00:59:03Z","timestamp":1780448343826,"version":"3.54.1"},"reference-count":9,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T00:00:00Z","timestamp":1663113600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"Introduction<\/jats:title>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.<\/jats:p><\/jats:sec>Methods<\/jats:title>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.<\/jats:p><\/jats:sec>Results<\/jats:title>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.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>Use of a novel composite topical lidocaine agent, demonstrated rapid and effective relief of pruritus ani in an ambulatory population. Additional studies are underway.<\/jats:p><\/jats:sec>Clinical trial registered<\/jats:title>Clinicaltrials.gov<\/jats:ext-link>, identifier NCT05288907.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2022.890883","type":"journal-article","created":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T06:18:24Z","timestamp":1663136304000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch"],"prefix":"10.3389","volume":"9","author":[{"given":"Isaac","family":"Felemovicius","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Ganz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad","family":"Saremi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Christopfel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2022,9,14]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"811","DOI":"10.1016\/S0733-8635(18)30725-3","article-title":"Pruritus ani","volume":"5","author":"Hanno","year":"1987","journal-title":"Classif Manag Dermatol Clin."},{"key":"B2","doi-asserted-by":"publisher","first-page":"505","DOI":"10.1016\/S0039-6109(16)41533-1","article-title":"Symposium on colon and anorectal surgery. Pruritus ani: a practical approach","volume":"58","author":"Sullivan","year":"1978","journal-title":"Surg Clin North Am."},{"key":"B3","doi-asserted-by":"publisher","first-page":"196","DOI":"10.1053\/j.scrs.2004.03.004","article-title":"Idiopathic pruritus ani","volume":"14","author":"Chaudry","year":"2003","journal-title":"Semin Colon Rectal Surg."},{"key":"B4","doi-asserted-by":"publisher","first-page":"358","DOI":"10.1007\/BF02553616","article-title":"Prospective studies on the etiology and treatment of pruritus ani","volume":"25","author":"Smith","year":"1982","journal-title":"Dis Colon Rectum."},{"key":"B5","doi-asserted-by":"publisher","first-page":"457","DOI":"10.1308\/003588408X317940","article-title":"Pruritus ani","volume":"90","author":"Siddiqi","year":"2008","journal-title":"Ann R Coll Surg."},{"key":"B6","doi-asserted-by":"publisher","first-page":"54","DOI":"10.3393\/jksc.2011.27.2.54","article-title":"Pruritus ani","volume":"27","author":"Song","year":"2011","journal-title":"Coloproctology."},{"key":"B7","unstructured":"BeechamG\n NesselTA\n GoyalA\n NIH StatPearls PublishingLidocaine. National Institute of Health StatPearls2022"},{"key":"B8","unstructured":"2022"},{"key":"B9","doi-asserted-by":"publisher","first-page":"66","DOI":"10.3390\/ph9040066","article-title":"Use of capsaicin to treat pain: mechanistic and therapeutic considerations","volume":"4","author":"Chung","year":"2016","journal-title":"Pharmaceuticals."}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2022.890883\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T06:18:29Z","timestamp":1663136309000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2022.890883\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,14]]},"references-count":9,"alternative-id":["10.3389\/fmed.2022.890883"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2022.890883","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,14]]},"article-number":"890883"}}