Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
Phase 3
Completed
- Conditions
- Skin Infections, Bacterial
- Registration Number
- NCT00133874
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.
- Detailed Description
A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria
Not provided
Exclusion Criteria
- Any signs and symptoms of systemic infection.
- Any serious underlying disease that could be imminently life threatening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment. 7 Days
- Secondary Outcome Measures
Name Time Method Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits. 7 Days
Trial Locations
- Locations (1)
GSK Investigational Site
πΏπ¦Pretoria, South Africa