The primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions. It will also be determined whether the efficacy of each of the active treatments is superior to that of the vehicle cream (placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,902
Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.
Bactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) applied topically 3 times per day for 10 consecutive days.
Cream vehicle of test product (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.
Clinical cure at visit 4
The proportion of subjects in each treatment group with clinical cure, defined as an SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).
Time frame: 7 days after end of treatment
Clinical cure at visit 3
The proportion of subjects with clinical cure at Visit 3/End of Treatment.
Time frame: Day 10 (visit 3)
Bacteriological cure at visit 3
The proportion of subjects with bacteriological cure, defined as elimination of S.aureus and S. pyogenes or response was such that no culture material was available and therefore evidence of pathogen eradication, at Visit 3/End of Treatment.
Time frame: Day 10 (visit 3)
Bacteriological cure at visit 4
Proportion of subjects with bacteriological cure at Visit 4/Follow-up.
Time frame: 7 days after end of treatment
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