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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014