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A Substantial Equivalence Study of RD04723 and Predicate Device

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01736969
Recruitment Status : Unknown
Verified November 2012 by Oculus Innovative Sciences, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : December 3, 2012
Sponsor:
Information provided by (Responsible Party):
Oculus Innovative Sciences, Inc.

Tracking Information
First Submitted Date  ICMJE October 12, 2012
First Posted Date  ICMJE November 29, 2012
Last Update Posted Date December 3, 2012
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination) [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
Vancouver Scar Scale [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
  • Pain and itch [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
    Patient assessment of pain and itch. Scoring from 0-3.
  • Adverse Events [ Time Frame: Baseline, Weeks: 2, 4, 8, 12 and early termination ]
    Number of subjects with related adverse events
  • Treatment satisfaction [ Time Frame: 8 weeks, 12 weeks ]
    Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Substantial Equivalence Study of RD04723 and Predicate Device
Official Title  ICMJE Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
Brief Summary The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertrophic Scar
  • Keloid Scar
Intervention  ICMJE
  • Device: RD047-023
    Experimental hydrogel
  • Device: Predicate Device
    Other Name: Kelo-Cote
Study Arms  ICMJE
  • Experimental: RD047-023
    RD-047-023
    Intervention: Device: RD047-023
  • Active Comparator: Predicate Device
    legally marketed predicate device
    Intervention: Device: Predicate Device
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 26, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to provide informed consent and release health information
  • Ability to follow study instructions and study requirements
  • Have a hypertrophic or keloid scar accessible for treatment and evaluation
  • Negative pregnancy test for women of childbearing potential
  • Agreement to use effective birth control method for study duration

Exclusion Criteria:

  • History of allergy or sensitivity to components
  • History of diabetes
  • History of collagen vascular disorders
  • Anticipated need for surgery or hospitalization during the study
  • Pregnant, nursing, or planning a pregnancy during the study
  • Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01736969
Other Study ID Numbers  ICMJE MSM-RD-023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oculus Innovative Sciences, Inc.
Study Sponsor  ICMJE Oculus Innovative Sciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janet C DuBois, MD Derm Research, PLLC
PRS Account Oculus Innovative Sciences, Inc.
Verification Date November 2012

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