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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155203
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Perrigo Company

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE October 15, 2019
Estimated Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
Clinical cure at Visit 4 [ Time Frame: 18 days ]
Defined as a Skin Infection Rating Scale (SIRS) score of 0 for all signs and symptoms at the Day 18 follow-up visit
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Secondarily Infected Traumatic Skin Lesions
Intervention  ICMJE
  • Drug: Mupirocin Calcium
    mupirocin cream
  • Drug: Mupirocin Calcium
    Reference mupirocin cream
  • Drug: Vehicle
    vehicle control cream
Study Arms  ICMJE
  • Experimental: Perrigo active
    Intervention: Drug: Mupirocin Calcium
  • Active Comparator: Reference Active
    Intervention: Drug: Mupirocin Calcium
  • Placebo Comparator: Vehicle control
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2020
Estimated Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fana Said 718-960-9951 fana.said@perrigo.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04155203
Other Study ID Numbers  ICMJE PRG-NY-19-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Perrigo Company
Study Sponsor  ICMJE Perrigo Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Perrigo Company
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP