Comparison of safety and efficacy of foam-based versus solution-based ciprofloxacin for acute otitis externa.
OBJECTIVE
To compare and evaluate the efficacy and safety of a foam-based antibiotic formulation in the treatment of acute otitis externa (AOE) with the more conventional solution-based formulation.


METHODS
Phase 2, open-label, randomized controlled trial.


METHODS
Multicenter.


METHODS
Sixty-three eligible adult patients with unilateral AOE were randomly assigned to one of two treatment groups: an experimental 0.3 percent foam-based ciprofloxacin, (FoamOtic Cipro) or 0.3 percent solution-based ciprofloxacin (Ciloxan). All patients received the same dose regime (twice daily for 7 days). The primary efficacy variable was response to therapy (cure) in the test-of-cure visit. Secondary variables included improvement of the disease symptoms otalgia, tenderness, edema, and otorrhea.


RESULTS
Sixty-four patients were enrolled in the study. Seven patients were excluded from the per-protocol analysis due to major deviations from the protocol. Per-protocol analysis (n = 57) showed that cure was achieved in all the patients (P = 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.


CONCLUSIONS
Foam-based ciprofloxacin is a safe and an effective new treatment for AOE.
Marom
Tal
T
Department of Otolaryngology-Head Neck Surgery, Edith Wolfson Medical Center, Tel-Aviv University Sackler School of Medicine, Holon, Israel. maromtal@orange.net
Yelin
Rodrigo
R
Goldfarb
Abraham
A
Rakover
Yoseph
Y
Shlizerman
Lev
L
Eilat
Eran
E
Roth
Yehudah
Y
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D004304:Dosage Forms; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010032:Otitis Externa / Q000188:drug therapy*; D010147:Pain Measurement; D012996:Solutions; D055815:Young Adult
D000900:Anti-Bacterial Agents; D004304:Dosage Forms; D012996:Solutions; D002939:Ciprofloxacin