Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials

October 2018 | Volume 17 | Issue 10 | Original Article | 1051 | Copyright © 2018

Adelaide A. Hebert MD,a Nuria Albareda MD,b Theodore Rosen MD,c Antonio Torrelo MD,d Ramon Grimalt MD,e Noah Rosenberg MD,f Ilonka Zsolt MD,b Xavier Masramon MDg

aDepartments of Dermatology and Pediatrics, UT Health McGovern Medical School, Houston, TX bFerrer Internacional. S.A, Barcelona, Spain cBaylor College of Medicine, Houston, TX dDepartment of Dermatology, Children’s Hospital del Niño Jesús, Madrid, Spain eUniversitat Internacional de Catalunya, Barcelona, Spain fMedimetriks Pharmaceuticals Inc., Fairfield, NJ gSAIL S.L. Barcelona, Spain

Abstract

Ozenoxacin is a novel topical antibacterial agent with potent bactericidal activity against Gram-positive bacteria that has been developed as a 1% cream for treatment of impetigo. This article presents pooled results of pivotal clinical trials of ozenoxacin with the objective of evaluating the efficacy, safety, and tolerability of ozenoxacin 1% cream after twice-daily topical treatment for 5 days in patients with impetigo. A pooled analysis was performed of individual patient data from two multicenter, randomized, double-blind, vehicle-controlled phase 3 registration studies conducted in patients with impetigo. Both clinical trials followed a similar methodology. Patients were randomized 1:1 to ozenoxacin or vehicle. One trial included retapamulin as an internal control. Efficacy was measured using the Skin Infection Rating Scale and microbiological culture. Safety and tolerability were evaluated. Ozenoxacin demonstrated superior clinical success versus vehicle after 5 days of therapy, superior microbiological success versus vehicle after 2 days of therapy, and was safe and well-tolerated. Ozenoxacin showed superior clinical and microbiological response versus vehicle in children as young as 2 months of age, and adults, with impetigo. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT01397461 and NCT02090764; European Clinical Trials Database Number: 2011-003032-31 and 2014-000228-52. J Drugs Dermatol. 2018;17(10):1051-1057.

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INTRODUCTION

Impetigo is the most common bacterial skin infection in children, although it can occur at any age.1-6 As impetigo is highly contagious, the condition is of particular concern in daycare centers and schools.7 Disease control is important to limit outbreaks, relieve symptoms, minimize scarring due to excoriation, and prevent rare but serious complications such as glomerulonephritis.8 This approach provides the rationale for antibiotic treatment of impetigo.9,10 More rapid clearance of skin lesions reduces the risk of contagion, which is particularly important in children. Clinical practice guidelines generally advocate use of topical antibacterials for localized impetigo, and oral antibiotics for patients with extensive lesions and those with systemic infection.11Staphylococcus aureus is the main causative pathogen of impetigo although Streptococcus pyogenes is sometimes involved.2,10,12,13 Resistance rates to commonly used topical antibiotics, such as mupirocin, are reported to be as high as 81%.14 Similarly, significant resistance rates of S. aureus to fusidic acid have emerged in a number of countries, potentially limiting its overall efficacy.15,16 Growing antibiotic resistance is a particular concern for patients who present with empirically managed diseases such as impetigo17 as patients are often treated without the benefit of culture and sensitivity results to guide appropriate care. New antibacterial agents with different modes of action to current drugs, and with activity against resistant strains, are clearly desirable.Ozenoxacin is a topical antibiotic that has demonstrated potent bactericidal activity against pathologically relevant Gram-positive organisms, particularly Staphylococci and Streptococci. Topical ozenoxacin has negligible systemic ab-

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