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

Ferrer Internacional S.A.465 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

465

Conditions

Impetigo

Interventions

ozenoxacin placeboDRUG

cream

retapamulin 1% ointmentDRUG

ointment

ozenoxacin 1% creamDRUG

1% cream

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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)

Locations (19)

Georg Popp

Augsburg, Germany

Klaus Chelius

Cologne, Germany

Roland Aschoff

Dresden, Germany

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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