Skin Infections, Bacterial
Conditions
Keywords
topical antibacterial, topical antibiotic, impetigo
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have primary impetigo with total lesion area being 100 square centimeters or less. * Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures.
Exclusion criteria
* Any signs and symptoms of systemic infection. * Any serious underlying disease that could be imminently life threatening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment. | 7 Days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, Costa Rica, France, Germany, India, Mexico, Netherlands, Peru, Poland, South Africa
Outcome results
None listed