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: ozenoxacin 1% cream; Drug: ozenoxacin placebo; Drug: retapamulin 1% ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01397461

P-110880-01

Details and patient eligibility

About

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.

Enrollment: 465 patients

Sex: All

Ages: 2+ years 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 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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465 participants in 3 patient groups, including a placebo group

ozenoxacin 1% cream

Experimental group

Description:

1% cream

Treatment:

Drug: ozenoxacin 1% cream

ozenoxacin placebo

Placebo Comparator group

Description:

cream

Treatment:

Drug: ozenoxacin placebo

retapamulin 1% ointment

Active Comparator group

Description:

1% ointment

Treatment:

Drug: retapamulin 1% ointment