{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T23:38:00Z","timestamp":1788910680784,"version":"build-2803163510"},"reference-count":14,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2010,10,1]],"date-time":"2010-10-01T00:00:00Z","timestamp":1285891200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["aao-hnsfjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Otolaryngol.--head neck surg."],"published-print":{"date-parts":[[2010,10]]},"abstract":"<jats:sec><jats:title>OBJECTIVE<\/jats:title><jats:p>To compare and evaluate the efficacy and safety of a foam\u2010based antibiotic formulation in the treatment of acute otitis externa (AOE) with the more conventional solution\u2010based formulation.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN<\/jats:title><jats:p>Phase 2, open\u2010label, randomized controlled trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>SETTING<\/jats:title><jats:p>Multicenter.<\/jats:p><\/jats:sec><jats:sec><jats:title>SUBJECTS AND METHODS<\/jats:title><jats:p>Sixty\u2010three eligible adult patients with unilateral AOE were randomly assigned to one of two treatment groups: an experimental 0.3 percent foam\u2010based ciprofloxacin, (FoamOtic Cipro) or 0.3 percent solution\u2010based ciprofloxacin (Ciloxan). All patients received the same dose regime (twice daily for 7\u00a0days). The primary efficacy variable was response to therapy (cure) in the test\u2010of\u2010cure visit. Secondary variables included improvement of the disease symptoms otalgia, tenderness, edema, and otorrhea.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Sixty\u2010four patients were enrolled in the study. Seven patients were excluded from the per\u2010protocol analysis due to major deviations from the protocol. Per\u2010protocol analysis (n = 57) showed that cure was achieved in all the patients (<jats:italic>P<\/jats:italic> = 1.000). No significant differences were found between groups for symptomatic relief, resolution of otic discharge, or onset of pain reduction. Both treatments were found to be highly efficacious and safe, demonstrating the noninferiority of the experimental drug.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>Foam\u2010based ciprofloxacin is a safe and an effective new treatment for AOE.<\/jats:p><\/jats:sec>","DOI":"10.1016\/j.otohns.2010.06.819","type":"journal-article","created":{"date-parts":[[2010,8,23]],"date-time":"2010-08-23T04:22:11Z","timestamp":1282537331000},"page":"492-499","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Comparison of safety and efficacy of foam\u2010based versus solution\u2010based ciprofloxacin for acute otitis externa"],"prefix":"10.1002","volume":"143","author":[{"given":"Tal","family":"Marom","sequence":"first","affiliation":[{"name":"Department of Otolaryngology\u2014Head Neck Surgery Edith Wolfson Medical Center Tel\u2010Aviv University Sackler School of Medicine Holon Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodrigo","family":"Yelin","sequence":"additional","affiliation":[{"name":"Otic Pharma Ltd. 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