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NCT02090764 Clinical Trial

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

Impetigo Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02090764
Other study ID # P-110881-01
Secondary ID
Status Recruiting
Phase Phase 3
First received March 17, 2014
Last updated March 5, 2015
Start date June 2014

Study information
Verified date March 2015
Source Ferrer Internacional S.A.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationPuerto Rico: Food and Drug AdministrationSouth Africa: Medicines Control CouncilGermany: The Bavarian State Ministry of the Environment and Public HealthRomania: Ministry of Public HealthSpain: Ministry of HealthRussia: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 412
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Months and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ozenoxacin

• Placebo

Locations
Country Name City State
Puerto Rico Caparra Internal Medicine Center Rio Grande

Sponsors (1)
Lead Sponsor Collaborator
Ferrer Internacional S.A.

Country where clinical trial is conducted

Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Response Visit 3 (Day 6-7) No
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