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

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

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 Overview

• Status: Completed
• Conditions: Impetigo
• Intervention / Treatment: Drug: ozenoxacin 1% cream; Drug: ozenoxacin placebo; Drug: retapamulin 1% ointment

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany
    • Georg Popp
  • Dresden, Germany
    • Roland Aschoff
  • Frankfurt/Main, Germany
    • Diamant Thaci
  • Köln, Germany
    • Klaus Chelius
  • Mahlow, Germany
    • Stephan Schilling
• South Africa
  • Benoni, South Africa
    • Ismail Mitha
  • Bloemfontein, South Africa
    • Johan Lombaard
  • Dundee, South Africa
    • Jan Fourie
  • George, South Africa
    • Dawie Kruger
  • Hatfield, South Africa
    • Philip Nel
  • Johannesburg, South Africa
    • Essack Mitha
  • Kraaifontein, South Africa
    • J Trokis
  • Middelburg, South Africa
    • Mohammed Tayob
  • Port Elizabeth, South Africa
    • Mashra Gani
  • Port Elizabeth, South Africa
    • Zelda Punt
  • Pretoria, South Africa
    • Molefe Phayane
  • Rondebosch, South Africa
    • Gail Todd
  • Welkom, South Africa
    • Yacoob Vahed
  • Worcester, South Africa
    • Christo van Dyk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ozenoxacin 1% cream; 1% cream	Drug: ozenoxacin 1% cream; 1% cream
Placebo Comparator: ozenoxacin placebo; cream	Drug: ozenoxacin placebo; cream
Active Comparator: retapamulin 1% ointment; 1% ointment	Drug: retapamulin 1% ointment; ointment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ferrer Internacional S.A.

Publications and helpful links

General Publications

• Hebert AA, Albareda N, Rosen T, Torrelo A, Grimalt R, Rosenberg N, Zsolt I, Masramon X. Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials. J Drugs Dermatol. 2018 Oct 1;17(10):1051-1057.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Staphylococcal Infections; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Impetigo; Anti-Infective Agents; Anti-Bacterial Agents; Retapamulin
• Other Study ID Numbers: P-110880-01