At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 412 enrolled
Drug / intervention
Ozenoxacin +1 moredrug
Likely dose
Ozenoxacin 1% cream applied twice daily for 5 daysAI-extracted
Key inclusion· 4
- ✓Clinical diagnosis of bullous or non-bullous impetigo
- ✓Total affected area 1–100 cm² with surrounding erythema ≤2 cm from edge; for multiple areas, sum total ≤100 cm²
- ✓For patients <12 years, total area ≤2% of body surface area
- ✓Total Skin Infection Rating Scale (SIRS) score ≥3 with pus/exudate score ≥1
Key exclusion· 2
- ✕Bacterial infection unsuitable for topical antibiotic treatment per investigator judgment
- ✕Systemic signs/symptoms of infection including fever (axillary temperature >37.2°C / >99.0°F)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III 2 Arms, Multicenter, Randomised, Double-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 and Placebo for Impetigo. Completed, enrolled 412 participants across 1 site.
Detailed Summary
This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImpetigo
CountriesPuerto Rico
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartJun 2014
Primary CompletionMay 2015
TodayJul 2026
First PostedMar 18, 2014
Enrollment StartJun 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.3 years ago
Interventions
Ozenoxacindrug
Placebodrug