Phase 3
N=465
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
Impetigo
Bottom Line
View on ClinicalTrials.gov: NCT01397461 ↗Enrolled (actual)
465
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Clinical Success — 34.8; 19.2; 37.7 percentage of participants — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ozenoxacin placebo (Drug); retapamulin 1% ointment (Drug); ozenoxacin 1% cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Ferrer Internacional S.A.
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success |
34.8; 19.2; 37.7 | 0.003 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area.
- Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1
Exclusion Criteria
- Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
- Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
Data sourced from ClinicalTrials.gov (NCT01397461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.