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
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.
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Ferrer Internacional S.A. |
Germany, South Africa,
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 |
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