Ozenoxacin (Xepi cream), a potent novel topical antibacterial agent, is effective and well tolerated for treatment of impetigo in patients aged 2 months and older, according to results of a phase 3 randomized, double-blind, vehicle-controlled clinical trial.
A 1% cream formulation of ozenoxacin had a clinical and microbiologic response that was rapid and superior to placebo, investigators reported in this second phase 3 pivotal study, which demonstrated the efficacy of ozenoxacin cream in impetigo patients.
Dr. Theodore Rosen
“With concerns over widespread antibiotic resistance, ozenoxacin is an important potential treatment option with an expanded spectrum against bacterial pathogens, including those resistant to mupirocin, ciprofloxacin, and methicillin, including MRSA [methicillin-resistant Staphylococcus aureus],” Dr. Rosen and his colleagues wrote in a report on their study in JAMA Dermatology.
The clinical trial included 412 patients aged 2 months or older with impetigo. Clinical success, defined as complete absence of the treated lesions, was seen after 5 days of treatment in 112 of the 206 (54.4%) patients randomized to ozenoxacin versus 78 of 206 patients (37.9%) who received placebo (P = .001), which confirmed the superiority of ozenoxacin, Dr. Rosen and his coauthors wrote.
In addition, microbiologic response was seen in 87.2% of patients in the ozenoxacin group during therapy (day 3) versus 63.9% in the placebo group (P = .002); by the end of therapy (day 6), response rates were 92.0% and 73.1%, respectively (P = .005).
All patients with drug-resistant infections had clinical cure or improvement at the end of treatment, including 10 patients with mupirocin-resistant S. aureus and 8 patients with MRSA, investigators wrote.
Adverse event rates were low for both ozenoxacin and placebo groups, at 3.9% and 3.4%, respectively. One patient in the ozenoxacin group experienced a serious adverse event “at least potentially related” to treatment (rosacea and seborrheic dermatitis).
“The lack of systemic adverse effects is consistent with previous studies that demonstrated that topically applied ozenoxacin has negligible systemic absorption,” Dr. Rosen and his coauthors wrote.
The study was partly supported by Ferrer Internacional; two coauthors of the study reported employment with that company. Dr. Rosen reported consulting work with Medimetriks Pharmaceuticals, which developed the agent.
SOURCE: Rosen T et al. JAMA Dermatol. 2018 Jun 13. doi: 10.1001/jamadermatol.2018.1103.