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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]
    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 ] [ 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".


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
RD-047-023
Device: RD047-023
Experimental hydrogel
Active Comparator: Predicate Device
legally marketed predicate device
Device: Predicate Device
Other Name: Kelo-Cote

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Oculus Innovative Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01736969     History of Changes
Other Study ID Numbers: MSM-RD-023
Study First Received: October 12, 2012
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014