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A Substantial Equivalence Study of RD04723 and Predicate Device

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oculus Innovative Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01736969
First received: October 12, 2012
Last updated: November 30, 2012
Last verified: November 2012
History of Changes

October 12, 2012
November 30, 2012
August 2012
March 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
Vancouver Scar Scale [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
Complete list of historical versions of study NCT01736969 on ClinicalTrials.gov Archive Site
  • Pain and itch [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Patient assessment of pain and itch. Scoring from 0-3.
  • Adverse Events [ Time Frame: Baseline, Weeks: 2, 4, 8, 12 and early termination ] [ Designated as safety issue: No ]
    Number of subjects with related adverse events
  • Treatment satisfaction [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".
Same as current
Not Provided
Not Provided
 
A Substantial Equivalence Study of RD04723 and Predicate Device
Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Hypertrophic Scar
  • Keloid Scar
  • Device: RD047-023
    Experimental hydrogel
  • Device: Predicate Device
    Other Name: Kelo-Cote
  • Experimental: RD047-023
    RD-047-023
    Intervention: Device: RD047-023
  • Active Comparator: Predicate Device
    legally marketed predicate device
    Intervention: Device: Predicate Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
March 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01736969
MSM-RD-023
No
Oculus Innovative Sciences, Inc.
Oculus Innovative Sciences, Inc.
Not Provided
Principal Investigator: Janet C DuBois, MD DermResearch Inc.
Oculus Innovative Sciences, Inc.
November 2012

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