A Substantial Equivalence Study of RD04723 and Predicate Device

November 30, 2012 updated by: Oculus Innovative Sciences, Inc.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Kelo-Cote

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain and itch
Time Frame: 4 weeks, 8 weeks, 12 weeks
Patient assessment of pain and itch. Scoring from 0-3.
4 weeks, 8 weeks, 12 weeks
Adverse Events
Time Frame: Baseline, Weeks: 2, 4, 8, 12 and early termination
Number of subjects with related adverse events
Baseline, Weeks: 2, 4, 8, 12 and early termination
Treatment satisfaction
Time Frame: 8 weeks, 12 weeks
Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".
8 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oculus Innovative Sciences, Inc.

Investigators

  • Principal Investigator: Janet C DuBois, MD, Derm Research, PLLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (ESTIMATE)

November 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSM-RD-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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