To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions
Condition: Secondarily Infected Traumatic Skin Lesions
Intervention: Mupirocin Calcium; Mupirocin Calcium; Vehicle
Intervention description: mupirocin cream; Reference mupirocin cream; vehicle control cream
Intervention MeSH terms: Calcium, Dietary; Mupirocin; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 657.0
Sex: All
Minimum age: 18 Months
Healthy volunteers: No

Summary:

      To compare the safety and efficacy of Perrigo's product to an FDA approved product, and to
      Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected
      Traumatic Skin Lesions
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or non-pregnant females aged 18 months or older.

          2. Must have a secondarily infected traumatic skin lesion such as a laceration, sutured
             wound, or abrasion.

          3. Must have a positive baseline culture for S. aureus and/or S. pyogenes from a sample
             taken from the secondarily infected traumatic skin lesion.

          4. Must have a positive Gram stain or Wright stain for confirmation of white blood cells
             in the pus/exudate from the secondarily infected traumatic skin lesion.

          5. Must have a Skin Infection Rating Scale (SIRS) total score for the secondarily
             infected traumatic skin lesion of at least 8 at baseline.

          6. Must be willing and able to understand and comply with the requirements of the study,
             apply the medication as instructed, and be able to complete the study.

          7. Must be in general good health and free from any clinically significant disease, other
             than secondarily infected traumatic skin lesion(s), that might interfere with the
             study evaluations.

        Exclusion Criteria:

          1. Subjects who are pregnant, breastfeeding, or planning a pregnancy within the period of
             their study participation.

          2. Presence of any dermatological disorder that may interfere with evaluation of the
             subject's secondarily infected traumatic skin lesion(s).

          3. Presence of bacterial skin infection that, because of depth or severity, could not be
             appropriately treated with a topical antibiotic.

          4. Presence of secondarily infected bite or puncture wound.

          5. Presence of systemic signs or symptoms of infection (fever defined as an oral
             temperature greater than 101°F or 38.3°C).

          6. Requirement for surgical intervention for treatment of the infection prior to study
             entry.

          7. Presence of cutaneous herpes simplex infections.

          8. Use of any topical corticosteroid, topical antibiotic, or topical antifungal, on the
             secondarily infected target lesion, within 48 hours prior to Visit 1/Day 1.

          9. Use of systemic antibiotics or systemic corticosteroids within 7 days of Visit 1/Day
             1.

         10. Primary or secondary immunodeficiency.

         11. Diagnosed Diabetes Mellitus (controlled or uncontrolled).

         12. Any uncontrolled, chronic or serious disease or medical condition that would prevent
             participation in a clinical trial, or, in judgment of the investigator, would put the
             subject at undue risk or might confound the study assessments.

         13. History of hypersensitivity or allergy to mupirocin and/or any ingredient in the study
             medication.

         14. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
             compromise the subject's ability to comply with study requirements.

         15. Subjects who, in the opinion of the investigator, are unlikely to be able to follow
             the restrictions of the protocol and complete the study.