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. STUDY DESIGN: Phase 2, open-label, randomized controlled trial. SETTING: Multicenter. SUBJECTS AND 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. CONCLUSION:Foam-based ciprofloxacin is a safe and an effective new treatment for AOE.
RCT Entities:
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. STUDY DESIGN: Phase 2, open-label, randomized controlled trial. SETTING: Multicenter. SUBJECTS AND 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. CONCLUSION: Foam-based ciprofloxacin is a safe and an effective new treatment for AOE.
Authors: Christina Tang; Edward Xiao; Patrick J Sinko; Zoltan Szekely; Robert K Prud'homme Journal: Colloids Surf B Biointerfaces Date: 2015-05-27 Impact factor: 5.268