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