Overview

Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Retapamulin
Criteria
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