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Efficacy and safety of ozenoxacin cream for treatment of adult and pediatric patients with impetigo: A randomized clinical trial

JAMA Dermatology Jun 20, 2018

Rosen T, et al. - Authors assessed the effectiveness, safety, and tolerability of ozenoxacin cream, 1%, after 5-day twice-daily topical treatment in patients with impetigo. Findings suggested effectiveness and well tolerability of topical ozenoxacin in the treatment of impetigo in patients 2 months and older. Rapid onset of response and superior clinical and microbiological response demonstrated this impact compared with placebo. For the treatment of impetigo a novel option was represented by topical ozenoxacin.

Methods

  • In this randomized, double-blind, vehicle-controlled clinical trial patients 2 months or older with impetigo were included who were enrolled at centers in 6 countries from June 2, 2014, through May 30, 2015.
  • Researchers analyzed the data based on intention to treat from July 9 through July 22, 2015.
  • They randomized 1:1 the patients to receive topical ozenoxacin or placebo control.
  • They measured the efficacy using the Skin Infection Rating Scale and microbiological culture.
  • They also assessed the safety and tolerability.

Results

  • As per the findings, among the 411 patients who received treatment (210 males [51.1%]; mean [SD] age, 18.6 [18.3] years), ozenoxacin demonstrated superior clinical success compared with placebo, which was evident after 5 days of therapy (112 of 206 [54.4%] vs 78 of 206 [37.9%];P=.001).
  • Results suggested that compared with placebo, ozenoxacin also demonstrated superior microbiological success after 2 days of therapy (109 of 125 [87.2%] vs 76 of 119 [63.9%]; P=.002).
  • With 8 of 206 patients experiencing adverse effects, ozenoxacin was well tolerated with only 1 of these potentially related to the study treatment; none were serious.

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