Status:
COMPLETED
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Skin Infections, Bacterial
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infe...
Detailed Description
This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- subject is aged 2 months or older
- subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
- negative urine pregnancy test
- subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3
- subject and/or parent/legal guardian is willing and able to comply with protocol
- subject or parent/legal guardian has given written informed consent or assent as applicable
- Exclusion criteria:
- previous hypersensitivity to pleuromutilin
- secondarily-infected animal/human bite or puncture wound
- subject has an abscess
- chronic ulcerative lesion
- underlying skin disease
- systemic signs and symptoms of infection
- infection not appropriately treated with topical antibiotic
- infection requires surgical intervention prior to or during study
- subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
- serious underlying disease
- subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
- other investigational drug within 30 days of study entry
- subject previously enrolled in this study
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT00684177
Start Date
May 1 2008
End Date
October 1 2009
Last Update
November 23 2016
Active Locations (54)
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1
GSK Investigational Site
Tucson, Arizona, United States, 85705
2
GSK Investigational Site
Anaheim, California, United States, 92804
3
GSK Investigational Site
Fresno, California, United States, 93710
4
GSK Investigational Site
Irvine, California, United States, 90620