Impetigo: ozenoxacin cream found safe, effective in phase 3 RCT

  • Rosen T & al.
  • JAMA Dermatol
  • 13 Jun 2018

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • A phase 3 randomized clinical trial (RCT) suggests that ozenoxacin cream, 1% (Xepi) is a safe and effective treatment option for adults and children with impetigo.

Why this matters

  • This trial suggests that ozenoxacin, a topical antibacterial agent, represents a novel treatment option for impetigo in patients aged 2 months and older.

Key results

  • Ozenoxacin patients experienced a superior rate of clinical success (total absence of the treated lesions) compared with placebo patients after 5 days (54.4% vs 37.9%; P=.001).
  • Ozenoxacin patients experienced a superior rate of microbiological success compared with placebo patients at visit 2 (87.2% vs 63.9%; P=.002) and visit 3 (92.0% vs 73.1%; P=.005).
  • The overall therapeutic success rate (combined clinical and microbiological response) was higher in ozenoxacin patients compared with placebo patients (57.6% vs 34.5%; P<.001>
  • 8/206 (3.9%) patients receiving ozenoxacin experienced adverse effects (1 potentially treatment-related).
    • There were no serious adverse effects.

Study design

  • 412 patients with impetigo aged 2 months or older were randomly assigned 1:1 to ozenoxacin or placebo and analyzed for efficacy and safety outcomes.
  • Funding: Ferrer Internacional, SA.

Limitations

  • Small number of children with bullous impetigo were included.
  • Limited data in children younger than 6 months.

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