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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

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ClinicalTrials.gov Identifier: NCT04155203
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Perrigo Company

Brief 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

Condition or disease Intervention/treatment Phase
Secondarily Infected Traumatic Skin Lesions Drug: Mupirocin Calcium Drug: Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Perrigo active Drug: Mupirocin Calcium
mupirocin cream

Active Comparator: Reference Active Drug: Mupirocin Calcium
Reference mupirocin cream

Placebo Comparator: Vehicle control Drug: Vehicle
vehicle control cream




Primary Outcome Measures :
  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) [ Time Frame: 18 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  11. Diagnosed Diabetes Mellitus (controlled or uncontrolled).
  12. 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.
  13. History of hypersensitivity or allergy to mupirocin and/or any ingredient in the study medication.
  14. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
  15. Subjects who, in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155203


Contacts
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Contact: Fana Said 718-960-9951 fana.said@perrigo.com

Locations
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United States, Florida
Palm Beach Research Center Recruiting
West Palm Beach, Florida, United States, 33409
Contact: David Scott    561-689-0606      
Sponsors and Collaborators
Perrigo Company

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Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT04155203     History of Changes
Other Study ID Numbers: PRG-NY-19-002
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Calcium, Dietary
Mupirocin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action