6.
Food and Drug Administration (DailyMed).
Publish date: September 1, 2023.
Clinical Studies
14 CLINICAL STUDIES The safety and efficacy of Xepi (ozenoxacin) for the treatment of impetigo was evaluated in two multi-center, randomized, double-blind placebo controlled clinical trials (Trial 1, (NCT01397461) and Trial 2, (NCT02090764)). Seven-hundred twenty-three (723) subjects two months of age and older with an affected body surface area of up to 100 cm 2, and not exceeding 2% for subjects aged 2 months to 11 years were randomized to Xepi (ozenoxacin) or placebo. Subjects applied Xepi (ozenoxacin) or placebo twice daily for 5 days. Subjects with underlying skin disease (e.g., preexisting eczematous dermatitis), skin trauma, clinical evidence of secondary infection, or systemic signs and symptoms of infection (such as fever), were excluded from these studies. Overall clinical success was defined as no need for additional antimicrobial therapy of the baseline affected area(s) and absence/reduction in clinical signs and symptoms assessed at the end of therapy (Day 6-7), as follows: absence of exudates/pus, crusting, tissue warmth, and pain; and erythema/inflammation, tissue edema, and itching assessed as less than mild in Trial 1; and absence of blistering, exudates/pus, crusting, and itching/pain, and mild or improved erythema/inflammation in Trial 2. Table 2 below presents the results for clinical response at the end of therapy. Table 2 Clinical Response at End of Therapy in Trial 1 and Trial 2 in All Randomized Subjects Trial 1 Trial 2 Xepi (ozenoxacin) Placebo Xepi (ozenoxacin) Placebo (N = 155) n (%) (N = 156) n (%) (N = 206) n (%) (N = 206) n (%) a The success rates for Xepi (ozenoxacin) were significantly different than placebo in Study 1 and Study 2 (p = 0.002 and p = 0.001).
Indications And Usage
1 INDICATIONS AND USAGE Xepi (ozenoxacin)™ is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older [see Clinical Studies (14) ]. Xepi (ozenoxacin) is a quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older ( 1 ).