NCT01397461

Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Ferrer Internacional S.A. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.

Conditions

• Impetigo

Interventions

Type	Name	Description
DRUG	ozenoxacin placebo	cream
DRUG	retapamulin 1% ointment	ointment
DRUG	ozenoxacin 1% cream	1% cream

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-07-19
• Last updated: 2016-07-01
• Results posted: 2016-05-18

Locations

19 sites across 2 countries: Germany, South Africa