CompletedNCT04155203Updated Nov 3, 2022Results posted

To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions

A Phase 3 interventional study of Mupirocin Calcium and Mupirocin Calcium in Secondarily Infected Traumatic Skin Lesions, sponsored by Padagis LLC. Completed at 1 site in United States. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2022-11-03.

Sponsored by Padagis LLC · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 657
Allocation: Randomized
Ages: 18 Months and older
Sex: All

Study 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

Conditions studied

Secondarily Infected Traumatic Skin Lesions

In context

Lead sponsor

Padagis LLC is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Browse Padagis LLC studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Months and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Males or non-pregnant females aged 18 months or older.
Must have a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.
Must have a positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
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.
Must have a Skin Infection Rating Scale (SIRS) total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.
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.
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

Exclusion Criteria:

Subjects who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
Presence of any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).
Presence of bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
Presence of secondarily infected bite or puncture wound.
Presence of systemic signs or symptoms of infection (fever defined as an oral temperature greater than 101°F or 38.3°C).
Requirement for surgical intervention for treatment of the infection prior to study entry.
Presence of cutaneous herpes simplex infections.
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.
Use of systemic antibiotics or systemic corticosteroids within 7 days of Visit 1/Day 1.
Primary or secondary immunodeficiency.
Diagnosed Diabetes Mellitus (controlled or uncontrolled).
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.
History of hypersensitivity or allergy to mupirocin and/or any ingredient in the study medication.
Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
Subjects who, in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 657 participants (actual)

Study arms

Experimental
Perrigo active
Drug: Mupirocin Calcium
Active comparator
Reference Active
Drug: Mupirocin Calcium
Placebo comparator
Vehicle control
Drug: Vehicle

Interventions

DrugMupirocin Calcium
mupirocin cream
DrugMupirocin Calcium
Reference mupirocin cream
DrugVehicle
vehicle control cream

What researchers measure

Primary outcomes

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

Results

Posted Nov 3, 2022

Participant flow

Participant flow — Overall Study
Milestone	Perrigo Active	Reference Active	Vehicle Control
Started	219	219	219
Completed	165	184	165
Not completed	54	35	54

Outcome measures

PrimaryProportion 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
Reported as:: Count of participants · Participants

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)
Participants	Perrigo Active	Reference Active	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)	145	169	124

Statistical analysis

Perrigo Active vs Reference Active · Equivalence ratio: 0.97 · 90% CI -8.19 to 2.70

Adverse events

Collected over From Day 1 to Day 17. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Perrigo Active	0/219 (0%)	0/219 (0%)	0/219 (0%)
Reference Active	0/219 (0%)	1/219 (0.5%)	0/219 (0%)
Vehicle Control	0/219 (0%)	0/219 (0%)	0/219 (0%)

Most frequent serious events

Most frequent serious events
Event	Perrigo Active	Reference Active	Vehicle Control
cellulitisSkin and subcutaneous tissue disorders	0/219	1/219	0/219

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Perrigo Active	Reference Active	Vehicle Control	Total
Mean	21.58 ± 16.924	20.81 ± 16.963	21.75 ± 17.089	21.38 ± 16.992

Age, Customized
Age, Customized(Participants)	Perrigo Active	Reference Active	Vehicle Control	Total
< 18 years old	100	103	94	297
18 to 63 years old	115	113	120	348
64 to 75 years old	4	3	5	12

Sex: Female, Male
Sex: Female, Male(Participants)	Perrigo Active	Reference Active	Vehicle Control	Total
Female	96	92	102	290
Male	123	127	117	367

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Perrigo Active	Reference Active	Vehicle Control	Total
Hispanic or Latino	217	219	218	654
Not Hispanic or Latino	2	0	1	3
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Perrigo Active	Reference Active	Vehicle Control	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	102	102	102	306
White	97	95	93	285
More than one race	0	0	0	0
Unknown or Not Reported	20	22	24	66

Study locations

1 site

Palm Beach Research Center
West Palm Beach, Florida 33409, United States

References and documents

Study documents

Study protocol · Feb 25, 2019
Statistical analysis plan · Feb 24, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2019 to primary completion in Jun 2021, 19 months.

Results were first posted in Nov 2022, 1 year 5 months after primary completion. A results delay was requested in May 2022.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 4, 2019
First posted: Nov 7, 2019
StartActual: Oct 15, 2019
Primary completionActual: Jun 1, 2021
CompletionActual: Jun 1, 2021
Results delay requested: May 23, 2022
Results first posted: Nov 3, 2022
Last update: Nov 3, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04155203
Lead sponsor: Padagis LLC
Responsible party: Sponsor
First posted: Nov 7, 2019
Start date: Oct 15, 2019
Primary completion: Jun 1, 2021
Completion: Jun 1, 2021
Results posted: Nov 3, 2022
Last update: Nov 3, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Mupirocin

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