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A Substantial Equivalence Study of RD04723 and Predicate Device

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Oculus Innovative Sciences, Inc..
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Oculus Innovative Sciences, Inc. Identifier:
First received: October 12, 2012
Last updated: November 30, 2012
Last verified: November 2012
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 Intervention
Hypertrophic Scar Keloid Scar Device: RD047-023 Device: Predicate Device

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Oculus Innovative Sciences, Inc.:

Primary Outcome Measures:
  • 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:
  • 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".

Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RD047-023
Device: RD047-023
Experimental hydrogel
Active Comparator: Predicate Device
legally marketed predicate device
Device: Predicate Device
Other Name: Kelo-Cote


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

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01736969

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

Responsible Party: Oculus Innovative Sciences, Inc. Identifier: NCT01736969     History of Changes
Other Study ID Numbers: MSM-RD-023
Study First Received: October 12, 2012
Last Updated: November 30, 2012

Additional relevant MeSH terms:
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Pathologic Processes processed this record on August 17, 2017