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

Ferrer

Status and phase

Completed

Phase 3

Conditions

Impetigo

Treatments

Drug: Placebo

Drug: Ozenoxacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02090764

P-110881-01

Details and patient eligibility

About

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.

Enrollment

412 patients

Sex

All

Ages

2+ months old

Volunteers

No Healthy Volunteers

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 3, 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)