Topical ozenoxacin 1% cream in impetigo: A systematic review and meta-analysis
Abstract
Background: Impetigo is a prevalent bacterial skin infection of the youngsters. Ozenoxacin is a new quinolone topical antibacterial agent that was developed as a 1% cream for the treatment of impetigo. Objective: The purpose of this study, which included a systematic review and meta-analysis, was to map the research and present the effectiveness of ozenoxacin 1% topical cream for treating impetigo. Methods: From the beginning to the end of the study period [July 2022], a thorough search was conducted on the PubMed, Google Scholar, Cochrane library, and Science Direct databases. According to clinical judgment and bacteriological testing, relevant studies that reported the success rate of ozenoxacin 1% topical cream in treating impetigo were included. Meta-analysis was done using the open-source software "R". The odds ratio was calculated along with the 95% confidence interval. To assess the level of certainty of the generated result, the GRADEpro tool was used. Results: This systematic review as well as meta-analysis included 4 clinical trials, two from Spain and two from the United States of America, with an approx of 1,874 cases, 957 of which used ozenoxacin 1% topical cream and 917 of which used placebo treatment. The fixed effect model showed that the use of ozenoxacin 1% topical cream is more effective than the use of placebo based on clinical judgment [OR= 2.16, 95% CI (1.77 − 2.65); P=<0.001; I2= 1%] and based on bacteriological culture testing results [OR= 4.15, 95% CI (3.08 – 5.57); P=<0.001; I2= 27.5%]. There is no evidence of publication bias or heterogeneity. The generated evidence is classified as having a high level of certainty. Conclusions: With a high certainty level of evidence, this meta-analysis showed that ozenoxacin 1% topical cream effectively treats impetigo over a placebo for both children and adult patients.References
Bowen AC, Mahé A, Hay RJ, et al. The Global Epidemiology of Impetigo: A Systematic Review of the Population Prevalence of Impetigo and Pyoderma. PLoS One. 2015;10(8):e0136789.
doi:10.1371/journal.pone.0136789
Cole C, Gazewood J. Diagnosis and treatment of impetigo. Am Fam Physician. 2007;75(6):859-64.
Karimkhani C, Dellavalle RP, Coffeng LE, et al. Global Skin Disease Morbidity and Mortality: An Update From the Global Burden of Disease Study 2013. JAMA Dermatol. 2017;153(5):406-12.
doi: 10.1001/jamadermatol.2016.5538.
Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014;59(2):147-159.
doi:10.1093/cid/ciu296
Hirschmann JV. Impetigo: etiology and therapy. Curr Clin Top Infect Dis. 2002;22:42-51.
Hartman-Adams H, Banvard C, Juckett G. Impetigo: diagnosis and treatment. Am Fam Physician. 2014;90(4):229-35.
Koning S, van der Sande R, Verhagen AP, et al. Interventions for impetigo. Cochrane Database Syst Rev. 2012;1(1):CD003261. doi:10.1002/14651858.CD003261.pub3
Gropper S, Albareda N, Santos B, Febbraro S. Systemic bioavailability, safety and tolerability of topical ozenoxacin in healthy adult volunteers. Future Microbiol. 2014;9(8 Suppl):S11-S16.
doi:10.2217/fmb.14.82
García Ron G, Villa Arranz M. New therapeutic applications of ozenoxacin in superficial skin infections. Dermatol Rep. 2021;14(2):9289. Published 2021 Aug 5. doi:10.4081/dr.2021.9289
Torrelo A, Grimalt R, Masramon X, Albareda López N, Zsolt I. Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents. Dermatology. 2020;236(3):199-207.
doi:10.1159/000504536
Eudaley S. Ozenoxacin (Xepi) for the Treatment of Impetigo. Am Fam Physician. 2020;101(12):760-1.
Wren C, Bell E, Eiland LS. Ozenoxacin: A Novel Topical Quinolone for Impetigo. Ann Pharmacother. 2018;52(12):1233-7.
doi:10.1177/1060028018786510
Sahu JK, Mishra AK. Ozenoxacin: A Novel Drug Discovery for the Treatment of Impetigo. Curr Drug Discov Technol. 2019;16(3):259-64. doi:10.2174/1570163815666180502165014
Canton R, Morrissey I, Vila J, et al. Comparative in vitro antibacterial activity of ozenoxacin against Gram-positive clinical isolates. Future Microbiol. 2018;13:3-19. doi:10.2217/fmb-2017-0289
Yamakawa T, Mitsuyama J, Hayashi K. In vitro and in vivo antibacterial activity of T-3912, a novel non-fluorinated topical quinolone. J Antimicrob Chemother. 2002;49(3):455-65. doi:10.1093/jac/49.3.455
Santhosh P, Thomas MH. Ozenoxacin: A novel topical antibiotic. Indian J Dermatol Venereol Leprol. 2021;87(1):131-4.
doi:10.25259/IJDVL_191_20
Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. Published 2021 Mar 29. doi:10.1136/bmj.n71
Munn Z, Tufanaru C, Aromataris E. JBI's systematic reviews: data extraction and synthesis. Am J Nurs. 2014;114(7):49-54. doi:10.1097/01.NAJ.0000451683.66447.89
Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials. 1996;17(1):1-12.
doi:10.1016/0197-2456(95)00134-4
Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
Published 2019 Aug 28. doi:10.1136/bmj.l4898
Rosen T, Albareda N, Rosenberg N, et al. Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial. JAMA Dermatol. 2018;154(7):806-13. doi:10.1001/jamadermatol.2018.1103
Balduzzi S, Rücker G, Schwarzer G. How to perform a meta-analysis with R: a practical tutorial. Evid Based Ment Health. 2019;22(4):153-60.
doi:10.1136/ebmental-2019-300117
Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength. J Clin Epidemiol. 2013;66(7):726-35.
doi:10.1016/j.jclinepi.2013.02.003
Gropper S, Albareda N, Chelius K, et al. Ozenoxacin 1% topical cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial. Future Microbiol. 2014;9(9):1013-23.
doi:10.2217/fmb.14.78
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):1051-7.
Williamson DA, Monecke S, Heffernan H, et al. High usage of topical fusidic acid and rapid clonal expansion of fusidic acid-resistant Staphylococcus aureus: a cautionary tale. Clin Infect Dis. 2014;59(10):1451-4.
doi:10.1093/cid/ciu658
García Ron G, Villa Arranz M. New therapeutic applications of ozenoxacin in superficial skin infections. Dermatol Rep. 2021;14(2):9289. Published 2021 Aug 5. doi:10.4081/dr.2021.9289.