Status:
COMPLETED
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
Lead Sponsor:
GlaxoSmithKline
Conditions:
Skin Infections, Bacterial
Eligibility:
All Genders
9+ years
Phase:
PHASE3
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 ...
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% ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00133874
Start Date
April 1 2005
End Date
September 1 2005
Last Update
January 23 2017
Active Locations (69)
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1
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A 1M3
2
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
3
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1E 2C2
4
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3J1