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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Impetigo

Intervention / Treatment
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* Drug: ozenoxacin placebo
* Drug: retapamulin 1% ointment
* Drug: ozenoxacin 1% cream


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ozenoxacin 1% cream<br>1% cream | Drug: ozenoxacin 1% cream<br>* 1% cream<br>|
| Placebo Comparator: ozenoxacin placebo<br>cream | Drug: ozenoxacin placebo<br>* cream<br>|
| Active Comparator: retapamulin 1% ointment<br>1% ointment | Drug: retapamulin 1% ointment<br>* ointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The SIRS is a severity index based on seven signs or symptoms: Exudate/pus Crusting Erythema/inflammation Tissue warmth Tissue oedema Itching Pain Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe | 2 weeks |