Evidence map›Paper›PMID 31958794›Full record

Trial reportDermatology (Basel, Switzerland)2020

Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents.

Antonio Torrelo, Ramon Grimalt, Xavier Masramon, Núria Albareda López, Ilonka Zsolt

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase III
In one paragraph

Trial report in Dermatology (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
6.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 37 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. What is new in dermatotherapy?Indian journal of dermatology, venereology and leprology
    Review
  10. Ozenoxacin: A novel topical antibiotic.Indian journal of dermatology, venereology and leprology
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Antonio TorreloDepartment of Dermatology, Children's Hospital del Niño Jesús, Madrid, Spain.
Ramon GrimaltUniversitat Internacional de Catalunya, Barcelona, Spain.
Xavier MasramonSAIL (Servicio de Asesoría a la Investigación y Logística) SL, Barcelona, Spain.
Núria Albareda LópezClinical Research Department, Ferrer Internacional SA, Barcelona, Spain.
Ilonka ZsoltMedical Department, Ferrer Internacional SA, Barcelona, Spain, izsolt@ferrer.com.
Ferrer Grupo (Spain) · ESHospital Infantil Universitario Niño Jesús · ESUniversitat Internacional de Catalunya · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOzenoxacin is a topical antibiotic approved in Europe to treat non-bullous impetigo in adults and children aged ≥6 months. This analysis evaluated the efficacy and safety of ozenoxacin in paediatric patients by age group.

methodsPooled data for patients aged 6 months to <18 years who had participated in a phase I or in two phase III clinical trials of ozenoxacin 1% cream were analysed by age group: 0.5-<2, 2-<6, 6-<12, and 12-<18 years.

resultsThe combined population comprised 529 patients with non-bullous impetigo treated with ozenoxacin (n = 239), vehicle (n = 201), or retapamulin as internal validation control (n = 89). Studies were well matched for extent and severity of impetigo and therapeutic schedule (twice daily application for 5 days). The clinical success rate after 5 days' treatment (day 6-7, end of therapy), and microbiological success rates after 3-4 days' treatment and at the end of therapy, were significantly higher with ozenoxacin than vehicle (p < 0.0001 for all comparisons). Clinical and bacterial eradication rates were higher with ozenoxacin than vehicle in each age group. No safety concerns were identified with ozenoxacin. One (0.3%) of 327 plasma samples exceeded the lower limit of quantification for ozenoxacin, but the low concentration indicated negligible systemic absorption.

conclusionThis combined analysis supports the efficacy and safety of ozenoxacin administered twice daily for 5 days. Ozenoxacin 1% cream is a new option to consider for treatment of non-bullous impetigo in children aged 6 months to <18 years.

Indexed as

Administration, TopicalAdolescentAminopyridinesAnti-Bacterial AgentsChildHumansImpetigoQuinolonesSkin CreamTreatment OutcomeAminopyridinesAnti-Bacterial AgentsozenoxacinQuinolonesEfficacyImpetigo, paediatricOzenoxacinSafetyTopical antibiotics

Identifiers

PMID31958794
PMCPMC7257257
OpenAlexW3001367250

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.