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A Phase III 3 Arms, Multicenter, Randomised, Investigator-blind Study to Assess the Efficacy and Safety of Ozenoxacin 1% Cream Applied Twice Daily for 5 Days Versus Placebo in the Treatment of Patients With Impetigo.[Multizentrische, randomisierte, 3-armige, prüferverblindete Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Ozenoxacin 1% Creme bei zweimal täglicher Anwendung über 5 Tage gegenüber Placebo zur Behandlung von Patienten mit Impetigo]

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Trial Profile

A Phase III 3 Arms, Multicenter, Randomised, Investigator-blind Study to Assess the Efficacy and Safety of Ozenoxacin 1% Cream Applied Twice Daily for 5 Days Versus Placebo in the Treatment of Patients With Impetigo.[Multizentrische, randomisierte, 3-armige, prüferverblindete Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Ozenoxacin 1% Creme bei zweimal täglicher Anwendung über 5 Tage gegenüber Placebo zur Behandlung von Patienten mit Impetigo]

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Dec 2017

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At a glance

  • Drugs Ozenoxacin (Primary) ; Retapamulin
  • Indications Bacterial infections; Impetigo
  • Focus Registrational; Therapeutic Use
  • Sponsors Ferrer

Most Recent Events

  • 14 Dec 2017 Results presented in a Medimetriks Pharmaceuticals media release.
  • 14 Dec 2017 According to a Medimetriks Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1% for the treatment of impetigo in patients two months of age and older when applied topically twice daily for 5 days. Based on the data from this and other trial (see profile 242379).
  • 08 May 2017 According to a Cipher Pharmaceuticals media release, based on the data from this and other trial (see profile 242379) the Health Canada has approved OZANEX™(ozenoxacin cream, 1%) indicated for the treatment of impetigo in patients aged 2 months and older.

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