Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the
safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3
or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S.
aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be
enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19
intermittent carriers complete the study. Each eligible subject will participate in three
screening visits, a treatment period, and two follow-up visits. Each subject's participation
in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit.
Subjects will participate in up to three screening visits to determine S. aureus culture
positivity and colonization status.
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects
(2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses,
or impetigo (bullous and non-bullous).
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
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.
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