Trial Outcomes & Findings for To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions (NCT NCT04155203)

NCT ID: NCT04155203

Last Updated: 2022-11-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 657 participants
• Primary outcome timeframe: 18 days
• Results posted on: 2022-11-03

Participant Flow

Participant milestones

Measure	Perrigo Active Mupirocin Calcium: mupirocin cream	Reference Active Mupirocin Calcium: Reference mupirocin cream	Vehicle Control Vehicle: vehicle control cream
Overall Study STARTED	219	219	219
Overall Study COMPLETED	165	184	165
Overall Study NOT COMPLETED	54	35	54

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Perrigo Active n=219 Participants Mupirocin Calcium: mupirocin cream	Reference Active n=219 Participants Mupirocin Calcium: Reference mupirocin cream	Vehicle Control n=219 Participants Vehicle: vehicle control cream	Total n=657 Participants Total of all reporting groups
Age, Continuous	21.58 years STANDARD_DEVIATION 16.924 • n=5 Participants	20.81 years STANDARD_DEVIATION 16.963 • n=7 Participants	21.75 years STANDARD_DEVIATION 17.089 • n=5 Participants	21.38 years STANDARD_DEVIATION 16.992 • n=4 Participants
Age, Customized < 18 years old	100 Participants n=5 Participants	103 Participants n=7 Participants	94 Participants n=5 Participants	297 Participants n=4 Participants
Age, Customized 18 to 63 years old	115 Participants n=5 Participants	113 Participants n=7 Participants	120 Participants n=5 Participants	348 Participants n=4 Participants
Age, Customized 64 to 75 years old	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	92 Participants n=7 Participants	102 Participants n=5 Participants	290 Participants n=4 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	127 Participants n=7 Participants	117 Participants n=5 Participants	367 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	217 Participants n=5 Participants	219 Participants n=7 Participants	218 Participants n=5 Participants	654 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	102 Participants n=5 Participants	102 Participants n=7 Participants	102 Participants n=5 Participants	306 Participants n=4 Participants
Race (NIH/OMB) White	97 Participants n=5 Participants	95 Participants n=7 Participants	93 Participants n=5 Participants	285 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	22 Participants n=7 Participants	24 Participants n=5 Participants	66 Participants n=4 Participants

PRIMARY outcome

Timeframe: 18 days

Outcome measures

Measure	Perrigo Active n=160 Participants Mupirocin Calcium: mupirocin cream	Reference Active n=181 Participants Mupirocin Calcium: Reference mupirocin cream	Vehicle Control n=168 Participants Vehicle: vehicle control cream
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	169 Participants	124 Participants

Adverse Events

Perrigo Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Active

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Perrigo Active n=219 participants at risk Mupirocin Calcium: mupirocin cream	Reference Active n=219 participants at risk Mupirocin Calcium: Reference mupirocin cream	Vehicle Control n=219 participants at risk Vehicle: vehicle control cream
Skin and subcutaneous tissue disorders cellulitis	0.00% 0/219 • From Day 1 to Day 17	0.46% 1/219 • Number of events 1 • From Day 1 to Day 17	0.00% 0/219 • From Day 1 to Day 17

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Schwartz

Padagis

Phone: 929-502-7291

Email: jonathan.schwartz@padagis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER