To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatm… (NCT04155203) | Clinical Trial Compass
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 range18 Months
SexALL
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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).
✕. Presence of bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
What they're measuring
1
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)
✕. 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.