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

Impetigo Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397461
• Other study ID #: P-110880-01
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2011
• Last updated: February 18, 2014
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Ferrer Internacional S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilIndia: Central Drugs Standard Control OrganizationUkraine: Ministry of HealthGermany: The Bavarian State Ministry of the Environment and Public HealthRomania: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years 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 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

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

Related Conditions & MeSH terms

• Impetigo

Intervention

Drug:
• ozenoxacin placebo
cream
• retapamulin 1% ointment
ointment
• ozenoxacin 1% cream
1% cream

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ferrer Internacional S.A.

Countries where clinical trial is conducted

Germany,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response (clinical success or clinical failure) at end of therapy (Visit 3, Day 6-7) in the intent-to-treat clinical (ITTC) population.		2 weeks	No