At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 465 enrolled
Drug / intervention
ozenoxacin placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating ozenoxacin placebo, retapamulin 1% ointment, and 1 other intervention for Impetigo. Completed, enrolled 465 participants across 19 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImpetigo
CountriesGermany, South Africa
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartMar 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedJul 19, 2011
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.0 years ago
Interventions
ozenoxacin placebodrug
cream
retapamulin 1% ointmentdrug
ointment
ozenoxacin 1% creamdrug
1% cream