Secondarily Infected Traumatic Skin Lesions
Conditions
Brief 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
Interventions
mupirocin cream
DRUGVehicle
vehicle control cream
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | 18 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perrigo Active Mupirocin Calcium: mupirocin cream | 219 |
| Reference Active Mupirocin Calcium: Reference mupirocin cream | 219 |
| Vehicle Control Vehicle: vehicle control cream | 219 |
| Total | 657 |
Baseline characteristics
| Characteristic | Reference Active | Vehicle Control | Total | Perrigo Active |
|---|---|---|---|---|
| Age, Continuous | 20.81 years STANDARD_DEVIATION 16.963 | 21.75 years STANDARD_DEVIATION 17.089 | 21.38 years STANDARD_DEVIATION 16.992 | 21.58 years STANDARD_DEVIATION 16.924 |
| Age, Customized 18 to 63 years old | 113 Participants | 120 Participants | 348 Participants | 115 Participants |
| Age, Customized < 18 years old | 103 Participants | 94 Participants | 297 Participants | 100 Participants |
| Age, Customized 64 to 75 years old | 3 Participants | 5 Participants | 12 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 219 Participants | 218 Participants | 654 Participants | 217 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 102 Participants | 102 Participants | 306 Participants | 102 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 24 Participants | 66 Participants | 20 Participants |
| Race (NIH/OMB) White | 95 Participants | 93 Participants | 285 Participants | 97 Participants |
| Sex: Female, Male Female | 92 Participants | 102 Participants | 290 Participants | 96 Participants |
| Sex: Female, Male Male | 127 Participants | 117 Participants | 367 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 219 | 0 / 219 | 0 / 219 |
| other Total, other adverse events | 0 / 219 | 0 / 219 | 0 / 219 |
| serious Total, serious adverse events | 0 / 219 | 1 / 219 | 0 / 219 |
Outcome results
Primary
Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms)
Time frame: 18 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Perrigo Active | Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | 145 Participants |
| Reference Active | Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | 169 Participants |
| Vehicle Control | Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | 124 Participants |
90% CI: [-8.19, 2.7]