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Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase III 2 Arms, Multicenter, Randomised, Double-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

NCT02090764•Ferrer Internacional S.A.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - No limit years

Sex

ALL

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)

Locations (1)

Caparra Internal Medicine Center

Río Grande, Puerto Rico

Key Dates

Start Date

June 1, 2014

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

August 20, 2024

Enrollment

412

ACTUAL participants

Conditions

Impetigo

Interventions

Ozenoxacin

DRUG

Placebo

DRUG

Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment

NCT00133848

Impetigo

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COMPLETEDPHASE4

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

NCT01126268

ImpetigoFolliculitis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

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