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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
520
Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
Time frame: 7 Days
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.
Time frame: 7 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada
GSK Investigational Site
Brampton, Ontario, Canada
GSK Investigational Site
Greater Sudbury, Ontario, Canada
GSK Investigational Site
Kitchener, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
San José, Costa Rica
GSK Investigational Site
Anzin, France
GSK Investigational Site
Bersée, France
...and 59 more locations