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

Completed · Phase 3 · Has a placebo group

Conditions studied: Skin Infections, Bacterial

In brief

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.

Key facts

Study ID

NCT00684177

Run by

GlaxoSmithKline

People needed

508

Starts

2008-05-01

Expected to finish

2009-10-01

Last updated by the study team

2016-11-23

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Deerfield Beach, Florida, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Panama City, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Vero Beach, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Arlington Heights, Illinois, United States
• GSK Investigational Site — Kansas City, Kansas, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Butte, Montana, United States
• GSK Investigational Site — Teaneck, New Jersey, United States
• GSK Investigational Site — Brooklyn, New York, United States
• GSK Investigational Site — Brooklyn, New York, United States
• GSK Investigational Site — East Syracuse, New York, United States
• GSK Investigational Site — Johnson City, New York, United States
• GSK Investigational Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.