November 29, 2018

Topical application twice daily of ozenoxacin 1% cream may decrease the spread of infection in children as young as 2 months of age.

The novel topical antibacterial agent ozenoxacin, which has potent bactericidal activity against Gram-positive bacteria, has demonstrated superior clinical microbiological response vs vehicle in adults and children as young as 2 months with impetigo. A pooled analysis was conducted of individual patient data from 2 multicenter, randomized, double-blind, vehicle-controlled, phase 3 registration studies (ClinicalTrials.gov identifiers: NCT01397461 and NCT02090764) on the subject, with both of the clinical trials following a similar methodology. Results from the pooled analysis were published in the Journal of Drugs in Dermatology.

The investigators sought to evaluate the efficacy, safety, and tolerability of ozenoxacin 1% cream after twice-daily topical application for 5 days in patients with impetigo. Patients were randomly assigned in a 1:1 ratio to treatment with ozenoxacin or vehicle. In study 1 only, retapamulin was included as an internal control. Efficacy was measured by means of the Skin Infection Rating Scale and microbiological culture.

The primary efficacy end point was clinical response (ie, clinical success or clinical failure) at the conclusion of treatment (visit 3) in the intent-to-treat clinical population. Secondary efficacy end points included clinical response (ie, clinical success and improvement of clinical failure) at visit 3, along with microbiological response at visits 2 and 3. Safety assessments were based on adverse events, vital signs, and physical examination.

The pooled analysis included individual data from 877 patients enrolled in the 2 phase 3 studies. Participants were from South Africa (n=390), the United States (n=212, including Puerto Rico [n=46]), Germany (n=125), Romania (n=63), Russia (n=57), Ukraine (n=27), and Spain (n=3). Participants were randomly assigned to receive ozenoxacin 1% cream (n=361), placebo cream (n=362), or retapamulin 1% ointment (n=154). Overall, 36 patients discontinued the study prematurely.

The clinical success rate for the pooled analysis at the end of therapy in the intent-to-treat clinical population was 47.3% in the ozenoxacin 1% arm vs 31.4% in the vehicle arm (P <.001). The proportion of participants who attained clinical cure and improvement at the completion of treatment was 88.5% in the ozenoxacin 1%, 78.2% in the placebo group (P <.0001), and 84.2% in the retapamulin group.

The proportion of participants who achieved eradication or presumed eradication of all evaluated pathogens was significantly higher in the ozenoxacin 1% arm than in the vehicle arm at visit 2 (80.4% vs 52.3%, respectively; P <.0001) and at visit 3 (90.8% vs 69.8%, respectively; P <.0001).

The investigators concluded that topical ozenoxacin 1% cream is a rapid and effective treatment for patients with impetigo. The agent demonstrates consistent clinical and bacteriologic effects and a favorable safety profile in children as young as 2 months of age. By reducing the symptoms of skin infection, ozenoxacin can decrease the spread of pathogens and lower the transmission of infection.

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Reference

Hebert AA, Albareda N, Rosen T, et al. Topical antibacterial agent for treatment of adult and pediatric patients with impetigo: pooled analysis of phase 3 clinical trials. J Drugs Dermatol. 2018;17(10):1051-1057.