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

Phase 3

Completed

• Conditions: Impetigo
• Interventions: Drug: ozenoxacin 1% cream; Drug: ozenoxacin placebo; Drug: retapamulin 1% ointment

• Registration Number: NCT01397461
• Lead Sponsor: Ferrer Internacional S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Study Start: 2012-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2016-02-25
• Results First Submitted QC: 2016-04-12
• Results First Posted: 2016-05-18
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 465

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ozenoxacin 1% cream	ozenoxacin 1% cream	1% cream
ozenoxacin placebo	ozenoxacin placebo	cream
retapamulin 1% ointment	retapamulin 1% ointment	1% ointment

Primary Outcome Measures

Name	Time	Method
Clinical Success	2 weeks	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

Trial Locations

Locations (19)

Georg Popp; 🇩🇪 Augsburg, Germany

Diamant Thaci; 🇩🇪 Frankfurt/Main, Germany

Yacoob Vahed; 🇿🇦 Welkom, South Africa

Dawie Kruger; 🇿🇦 George, South Africa

Mashra Gani; 🇿🇦 Port Elizabeth, South Africa

Roland Aschoff; 🇩🇪 Dresden, Germany

Essack Mitha; 🇿🇦 Johannesburg, South Africa

Gail Todd; 🇿🇦 Rondebosch, South Africa

Zelda Punt; 🇿🇦 Port Elizabeth, South Africa

Philip Nel; 🇿🇦 Hatfield, South Africa

Klaus Chelius; 🇩🇪 Köln, Germany

Jan Fourie; 🇿🇦 Dundee, South Africa

Ismail Mitha; 🇿🇦 Benoni, South Africa

Mohammed Tayob; 🇿🇦 Middelburg, South Africa

Molefe Phayane; 🇿🇦 Pretoria, South Africa

Johan Lombaard; 🇿🇦 Bloemfontein, South Africa

J Trokis; 🇿🇦 Kraaifontein, South Africa

Stephan Schilling; 🇩🇪 Mahlow, Germany

Christo van Dyk; 🇿🇦 Worcester, South Africa