Efficacy and Safety of Ozenoxacin 1% Cream 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.

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Key information

Conditions

Impetigo Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Streptococcal Infections

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Georg Popp, Augsburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ozenoxacin placebo

Drug

cream

retapamulin 1% ointment

Drug

ointment

ozenoxacin 1% cream

Drug

1% cream

Primary outcomes

Clinical Success

Time frame: 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

Sponsors and collaborators

Lead sponsor

Ferrer Internacional S.A.

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jul 19, 2011
Registry last updated: Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed