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

COMPLETEDPHASE3

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

Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Mupirocin Cream to A Reference Manufacturer's Mupirocin Cream and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions

NCT04155203•Padagis LLC

View on ClinicalTrials.gov

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

Age

1 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (1)

Palm Beach Research Center

West Palm Beach, Florida, United States

Key Dates

Start Date

October 15, 2019

Primary Completion Date

June 1, 2021

Completion Date

June 1, 2021

Last Updated

November 3, 2022

Enrollment

657

ACTUAL participants

Conditions

Secondarily Infected Traumatic Skin Lesions

Interventions

Mupirocin Calcium

DRUG

Mupirocin Calcium

DRUG

Vehicle

DRUG