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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mupirocin Calcium Cream, 2% | Experimental | Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) |
|
| Bactroban® Cream | Active Comparator | Bactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) |
|
| Cream vehicle of test product | Placebo Comparator | Cream vehicle of test product (Taro Pharmaceuticals Inc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin Calcium Cream, 2% | Drug | Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure at visit 3 | The proportion of subjects with clinical cure at Visit 3/End of Treatment. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Symbio CRO | http://symbioresearch.com | Study Chair |
| Catawba Research, LLC | https://catawbaresearch.com/ | Study Chair |
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| Bactroban® Cream | Drug | Bactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) applied topically 3 times per day for 10 consecutive days. |
|
| Cream vehicle of test product | Drug | Cream vehicle of test product (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days. |
|
| Day 10 (visit 3) |
| Bacteriological cure at visit 4 | Proportion of subjects with bacteriological cure at Visit 4/Follow-up. | 7 days after end of treatment |