Safety and efficacy profile of ozenoxacin 1% cream in pediatric patients with impetigo.

Antibiotic Impetigo Ozenoxacin Pediatrics Safety Topical

Journal

International journal of women's dermatology
ISSN: 2352-6475
Titre abrégé: Int J Womens Dermatol
Pays: United States
ID NLM: 101654170

Informations de publication

Date de publication:
Mar 2020
Historique:
received: 06 06 2019
revised: 16 09 2019
accepted: 23 10 2019
entrez: 8 4 2020
pubmed: 8 4 2020
medline: 8 4 2020
Statut: epublish

Résumé

Ozenoxacin is a topical antibiotic approved in the United States for treatment of impetigo in adults and children age ≥2 months. This analysis evaluated the efficacy and safety of ozenoxacin in specific pediatric age groups. Data for children aged 2 months to <18 years recruited from eight countries who had participated in phase 1 and 3 trials of ozenoxacin were extracted and analyzed by age range. Across studies, 644 pediatric patients with impetigo received ozenoxacin 1% cream (n = 287) or vehicle (n = 247). One study included retapamulin 1% ointment as the internal validity control (n = 110). The clinical success rate at the end of treatment and bacterial eradication rates after 3 to 4 days of treatment and at the end of treatment were significantly higher with ozenoxacin than vehicle (all The results of this analysis suggest that ozenoxacin 1% cream is an effective and safe treatment for impetigo in pediatric patients aged 2 months to <18 years.

Sections du résumé

BACKGROUND BACKGROUND
Ozenoxacin is a topical antibiotic approved in the United States for treatment of impetigo in adults and children age ≥2 months. This analysis evaluated the efficacy and safety of ozenoxacin in specific pediatric age groups.
METHODS METHODS
Data for children aged 2 months to <18 years recruited from eight countries who had participated in phase 1 and 3 trials of ozenoxacin were extracted and analyzed by age range.
RESULTS RESULTS
Across studies, 644 pediatric patients with impetigo received ozenoxacin 1% cream (n = 287) or vehicle (n = 247). One study included retapamulin 1% ointment as the internal validity control (n = 110). The clinical success rate at the end of treatment and bacterial eradication rates after 3 to 4 days of treatment and at the end of treatment were significantly higher with ozenoxacin than vehicle (all
CONCLUSION CONCLUSIONS
The results of this analysis suggest that ozenoxacin 1% cream is an effective and safe treatment for impetigo in pediatric patients aged 2 months to <18 years.

Identifiants

pubmed: 32258344
doi: 10.1016/j.ijwd.2019.10.008
pii: S2352-6475(19)30116-9
pmc: PMC7105648
doi:

Types de publication

Journal Article

Langues

eng

Pagination

109-115

Informations de copyright

© 2019 Published by Elsevier Inc. on behalf of Women's Dermatologic Society.

Références

Future Microbiol. 2014;9(9):1013-23
pubmed: 25340832
Future Microbiol. 2014;9(8 Suppl):S33-40
pubmed: 25209523
J Antimicrob Chemother. 2015 Oct;70(10):2681-92
pubmed: 26142407
Antimicrob Agents Chemother. 2007 Nov;51(11):3880-6
pubmed: 17724154
Antimicrob Agents Chemother. 2015;59(6):3350-6
pubmed: 25824213
Future Microbiol. 2018 May 1;13:3-19
pubmed: 29745242
JAMA Dermatol. 2018 Jul 1;154(7):806-813
pubmed: 29898217
Antimicrob Agents Chemother. 2013 Dec;57(12):6389-92
pubmed: 24080666
BMJ. 2004 Jul 10;329(7457):95-9
pubmed: 15242915
Mayo Clin Proc. 2011 Nov;86(11):1113-23
pubmed: 22033257
Expert Opin Pharmacother. 2005 Oct;6(13):2245-56
pubmed: 16218885
Future Microbiol. 2014;9(8 Suppl):S11-6
pubmed: 25209519
Future Microbiol. 2018 May 1;13:31-40
pubmed: 29745239
Antimicrob Agents Chemother. 2010 Sep;54(9):3614-7
pubmed: 20566766
Future Microbiol. 2014;9(8 Suppl):S23-31
pubmed: 25209521
Antimicrob Agents Chemother. 2011 May;55(5):2431-3
pubmed: 21282426
PLoS One. 2015 Aug 28;10(8):e0136789
pubmed: 26317533
Int J Antimicrob Agents. 2010 Mar;35(3):282-7
pubmed: 20036520
J Antimicrob Chemother. 2010 Jul;65(7):1353-8
pubmed: 20430787
Acta Derm Venereol. 2010;90(1):52-7
pubmed: 20107726
Expert Rev Anti Infect Ther. 2019 Mar;17(3):159-168
pubmed: 30686133
Clin Infect Dis. 2006 Feb 1;42(3):394-400
pubmed: 16392088
Am Fam Physician. 2007 Mar 15;75(6):859-64
pubmed: 17390597
Clin Infect Dis. 2014 Jul 15;59(2):147-59
pubmed: 24947530
Int J Dermatol. 2003 Apr;42(4):251-5
pubmed: 12694487

Auteurs

Adelaide A Hebert (AA)

Department of Dermatology and Pediatrics, UTHealth McGovern Medical School, Houston, TX, United States.

Theodore Rosen (T)

Department of Dermatology, Baylor College of Medicine, Houston, TX, United States.

Núria Albareda López (N)

Clinical Research Department, Ferrer Internacional, Barcelona, Spain.

Ilonka Zsolt (I)

Medical Department, Ferrer Internacional, Barcelona, Spain.

Xavier Masramon (X)

Servicio de Asesoría a la Investigación y Logística, Barcelona, Spain.

Classifications MeSH