"Ozenoxacin" from_date:2012

Ozanex - Ozenoxacin Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More servicesYou are here: 1. HomeSummary Basis of Decision - - Health Canada * Drugs

Ozenoxacin (Xepi) - To treat impetigo Xepi (ozenoxacin) Cream * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDAXepi (ozenoxacin) Cream * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print XepiCompany: Ferrer Internacional S.A.Application No.: 208945Approval Date: 12/11/2017Persons with disabilities having problems accessing the PDF

Ozenoxacin An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM and EffectsSummary of Use during LactationNo information is available on ozenoxacin cream during breastfeeding. Because ozenoxacin is poorly absorbed after topical application, it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants after maternal application away from the breast. Although quinolones are generally acceptable for systemic use, ozenoxacin should

Comparative activity of ozenoxacin and other quinolones in Staphylococcus aureus strains overexpressing the efflux pump-encoding genes mepA and norA. To evaluate the activity of ozenoxacin (OZN) in Staphylococcus aureus strains overexpressing the efflux pump-encoding genes mepA and norA. S. aureus NCTC-8325-1, S. aureus NCTC 8225-2 (overexpressing mepA), S. aureus SA 1199 and S. aureus SA 1199B

Ozenoxacin Cream, 1% - Topical Treatment of Impetigo.

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial. Ozenoxacin, a novel topical antibacterial agent with potent bactericidal activity against gram-positive bacteria, has been developed as a cream with 1% active drug for the treatment of impetigo, a highly contagious bacterial skin infection. To evaluate the efficacy , safety, and tolerability of ozenoxacin cream, 1%, after 5-day twice-daily topical treatment in patients with impetigo. This randomized, double-blind, vehicle-controlled clinical trial included patients 2 months or older with impetigo who were enrolled at centers in 6 countries from June 2, 2014, through May 30, 2015. Data were analyzed based on intention to treat from July 9 through July 22, 2015

Efficacy of ozenoxacin 1% in pediatric and adult patients with impetigo: A meta-analysis of randomized trials PROSPERO International prospective register of systematic reviews Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms

Antimicrobial activities of ozenoxacin against the isolates of propionibacteria and staphylococci from Japanese patients with acne vulgaris. Ozenoxacin, a novel non-fluorinated topical quinolone, was assessed for in vitro antimicrobial activity against clinical isolates of propionibacteria and staphylococci according to the broth microdilution method recommended by the Clinical and Laboratory Standards Institute. The isolates used in this study were collected from Japanese patients with acne vulgaris during a period from 2012 to 2013. The MIC90s of ozenoxacin against Propionibacterium acnes (n=266), Propionibacterium granulosum (n=10), Staphylococcus aureus (n=23), Staphylococcus epidermidis (n=229) and other coagulase-negative staphylococci (n=82) were ≤0.06, ≤0.06, ≤0.06, 0.125 and ≤0.06 µg

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Systematic Review and Meta-analysis PROSPEROInternational prospective register of systematic reviews Print | PDFEfficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Systematic Review and Meta-analysisDhaii Alzahrani, Ghadi Alharbi, Amal . Further detail is provided here.CitationDhaii Alzahrani, Ghadi Alharbi, Amal Aboaloula, Rami Jan, Awadh Alamri. Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Systematic Review and Meta-analysis. PROSPERO 2023 CRD42023484198 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023484198Review questionIs topical Ozenoxacin

Cumulative irritation, sensitizing potential, phototoxicity and photoallergy of ozenoxacin in healthy adult volunteers. In this series of Phase I, randomized, placebo-controlled studies in healthy volunteers, the potential for ozenoxacin 1 and 2% cream formulations to cause irritation, sensitization, phototoxicity and photoallergy under occlusive patch conditions was evaluated. Both ozenoxacin formulations showed excellent dermal tolerability; in the vast majority of cases, only minimal signs of erythema were observed, with no evidence of edema or a papular response. No subject met the criteria for a phototoxic reaction with the ozenoxacin 1 or 2% cream formulations. Only a few adverse events were reported across repeated-dose studies, and virtually all events were considered to be unrelated

Systemic bioavailability, safety and tolerability of topical ozenoxacin in healthy adult volunteers. A series of Phase I studies was conducted in healthy volunteers to examine the systemic bioavailability and safety of topical ozenoxacin. Study 1 examined increasing single doses (relating to quantity and body surface area) of ozenoxacin 1% ointment. Study 2 compared multiple doses of ozenoxacin 1 % ointment and placebo applied for 7 days. Study 3 investigated multiple doses of ozenoxacin 2% cream and placebo applied for 7 days. Study 4 examined multiple doses of ozenoxacin 2% cream applied to intact and abraded skin for 8 days. No systemic absorption was observed in any study and ozenoxacin was well tolerated. The most common treatment-related adverse events were application-site reactions

In vitro selection of mutants resistant to ozenoxacin compared with levofloxacin and ciprofloxacin in Gram-positive cocci. To determine the frequency of selecting mutants resistant to ozenoxacin, a des-fluoro-(6)-quinolone active against pathogens involved in skin and skin structure infections, compared with levofloxacin and ciprofloxacin in quinolone-susceptible and -resistant Gram-positive cocci. Forty-nine quinolone-susceptible and -resistant Gram-positive cocci strains with different profiles of mutations in the quinolone resistance-determining region (QRDR) were examined to determine the frequency of selecting mutants resistant to ozenoxacin compared with levofloxacin and ciprofloxacin. MICs and mutations in the QRDR were determined by standard broth microdilution and PCR

Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial. We compared the efficacy and safety of ozenoxacin (a new nonfluorinated quinolone) 1% cream with placebo in the treatment of impetigo. In a randomized, double-blind, multicenter study, patients received ozenoxacin cream or placebo cream twice daily for 5 days (a third group received retapamulin 1% ointment as a control). Clinical, microbiological and laboratory evaluations were performed during follow-up (over 2 weeks). Ozenoxacin was superior to placebo (success rate 34.8 vs 19.2%; p = 0.003). Microbiological success was 70.8% for ozenoxacin and 38.2% for placebo after 3-4 days and 79.2% versus 56.6% after 6-7 days. Ozenoxacin produced more rapid microbiological

Systemic bioavailability and safety of twice-daily topical ozenoxacin 1% cream in adults and children with impetigo. In this Phase I open-label study, the systemic absorption, clinical response, safety and tolerability of multiple-dose ozenoxacin 1% cream were evaluated in children (≥ 2 months of age) and adults with impetigo. A single (evening) dose of ozenoxacin 1% cream on day 1 was followed by twice-daily application for 4 days (every 12 h), and then a final single (morning) dose on day 6. A total of 46 patients were enrolled in the study. The majority of ozenoxacin plasma samples were below the limit of quantification (no systemic absorption). Approximately half (22/45) of the evaluable patients achieved clinical success (skin lesions were cured). No patients were withdrawn from the study

Skin tissue exposure of once- versus twice-daily topical ozenoxacin 2% cream: a Phase I study in healthy volunteers. In this Phase I study, healthy volunteers (n = 24) were randomly allocated to receive either one or two 0.2-g applications per day (12 h apart) of ozenoxacin 2% cream on three different areas of the back for 3 consecutive days. Ozenoxacin concentrations were measured in tape stripping samples (from the stratum corneum) and in skin punch biopsy samples (from the epidermis and dermis) taken predose from selected dosing areas on study days 2, 3 and 4. Ozenoxacin concentrations were high in the stratum corneum and were approximately twofold greater for the twice- versus once-daily application. Ozenoxacin concentrations were low in the epidermis and were higher for the twice

Ozenoxacin 1% cream for the treatment of impetigo a systematic review and meta-analysis Ozenoxacin 1% cream for the treatment of impetigo a systematic review and meta-analysis Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms

In vitro activity of Ozenoxacin against Gram-positive bacteria susceptible and resistant to other quinolones. In vitro activity of ozenoxacin, a novel nonfluorinated topical (L. D. Saravolatz and J. Leggett, Clin. Infect. Dis. 37:1210-1215, 2003) quinolone, was compared with the activities of other quinolones against well-characterized quinolone-susceptible and quinolone-resistant Gram-positive bacteria. Ozenoxacin was 3-fold to 321-fold more active than other quinolones. Ozenoxacin could represent a first-in-class nonfluorinated quinolone for the topical treatment of a broad range of dermatological infections.

on their history of antibiotic use, and between localities. There was some evidence showing that topical ozenoxacin is more effective than placebo for treating impetigo. However, because the evidence did not compare topical ozenoxacin with another antibiotic, the committee could not make recommendations for its use. It was also noted that topical ozenoxacin is not currently available in the UK. Based on its : • mupirocin in adults, young people and children • fusidic acid in children • ozenoxacin in children. Efficacy of oral antibiotics Efficacy of oral antibiotics Phenoxymethylpenicillin was not statistically significantly different compared with placebo in children for the outcome of cure or improvement. Topical antibiotics compared with antiseptics, steroids or Topical antibiotics compared with antiseptics

and cephalexin in the treatment of secondarily infected eczema. Clin Exp Dermatol. 2002 Jan. 27(1):14-20. [QxMD MEDLINE Link]. 64. Albareda, N, Rosenberg, N., Roth, S, et al. Ozenoxacin, a Novel, Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients with Impetigo: Phase III Clinical Trials Pooled Analysis Results. SKIN The Journal of Cutaneous Medicine. 2017. 1(3.1):s102. [Full Text]. 65. Gropper S, Albareda N, Chelius K, Kruger D, Mitha I, Vahed Y, et al. Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial. Future Microbiol. 2014. 9 (9):1013-23. [QxMD MEDLINE Link]. 66. Chamny S, Miron D, Lumelsky N, Shalev H, Gazal E, Keynan R, et al. Topical Minocycline Foam for the Treatment

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