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A Substantial Equivalence Study of RD04723 and Predicate Device

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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.

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.

Condition or disease Intervention/treatment Phase
Hypertrophic Scar Keloid Scar Device: RD047-023 Device: Predicate Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
Study Start Date : August 2012
Estimated Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: RD047-023
RD-047-023
Device: RD047-023
Experimental hydrogel

Active Comparator: Predicate Device
legally marketed predicate device
Device: Predicate Device
Other Name: Kelo-Cote




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain and itch [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
    Patient assessment of pain and itch. Scoring from 0-3.

  2. Adverse Events [ Time Frame: Baseline, Weeks: 2, 4, 8, 12 and early termination ]
    Number of subjects with related adverse events

  3. Treatment satisfaction [ Time Frame: 8 weeks, 12 weeks ]
    Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT01736969


Locations
United States, Texas
DermResearch Inc
Austin, Texas, United States, 78759
Sponsors and Collaborators
Oculus Innovative Sciences, Inc.
Investigators
Principal Investigator: Janet C DuBois, MD DermResearch, Inc

Responsible Party: Oculus Innovative Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01736969     History of Changes
Other Study ID Numbers: MSM-RD-023
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Hypertrophy
Keloid
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes