Skin Infections, Bacterial Clinical Trial
Official title:
A Randomized, Double-Blind, Multicenter, Placebo-controlled, Phase III Superiority Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adult and Pediatric Subjects With 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.
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 abrasions. A laceration or sutured wound cannot exceed 10 cm in length
with surrounding erythema not extending more than 2 cm from the edge of the lesion.
Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface
area for subjects <18 years of age, with surrounding erythema not extending more than 2 cm
from the edge of the abrasion.
There are four study visits occurring over a 12-14 day period. At the Baseline visit (Visit
1, Day 1), subjects will be randomized to receive retapamulin or placebo ointment in a 2:1
(retapamulin:placebo) ratio. The 2:1 randomization is included to minimize the number of
subjects exposed to treatment with placebo. Both active treatment and placebo will be dosed
topically twice daily (BID) for 5 days. All subjects will receive a telephone call from the
investigator or appropriate designee appointed by the investigator on Day 2. The subject
will be interviewed to determine if there is any evidence of worsening infection. Subjects
who are thought to be worsening will be instructed to come in to the clinic for an
assessment. Subjects will be monitored and clinically evaluated at the On-therapy (Days
3-4), End of Therapy (Days 7-9), and Follow-up (Days 12-14) visits.
Randomization will be center-based and performed using an appropriate Interactive Voice
Response System (IVRS), an automated telephone system. The block size will remain
confidential.
Subjects are considered to have completed the study if they meet all inclusion/exclusion
criteria, are considered compliant with study medication, and attend all study visits as
defined by the protocol.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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