CompletedPhase 3

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

United States657 participantsStarted 2019-10-15

Plain-language 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

Who can participate

Age range

18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Timeframe: 18 days

Trial details

NCT IDNCT04155203

SponsorPadagis LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-01

Results submitted2022-10-12

View on ClinicalTrials.gov More Secondarily Infected Traumatic Skin Lesions trials