Back to resultsA Substantial Equivalence Study of RD04723 and Predicate Device
Primary Purpose
Hypertrophic Scar, Keloid Scar
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RD047-023
Predicate Device
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Scar
Eligibility 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)
Sites / Locations
- DermResearch Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RD047-023
Predicate Device
Arm Description
RD-047-023
legally marketed predicate device
Outcomes
Primary Outcome Measures
Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)
Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
Secondary Outcome Measures
Pain and itch
Patient assessment of pain and itch. Scoring from 0-3.
Adverse Events
Number of subjects with related adverse events
Treatment satisfaction
Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".
Full Information
NCT ID
NCT01736969
First Posted
October 12, 2012
Last Updated
November 30, 2012
Sponsor
Oculus Innovative Sciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01736969
Brief Title
A Substantial Equivalence Study of RD04723 and Predicate Device
Official Title
Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculus Innovative Sciences, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar, Keloid Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RD047-023
Arm Type
Experimental
Arm Description
RD-047-023
Arm Title
Predicate Device
Arm Type
Active Comparator
Arm Description
legally marketed predicate device
Intervention Type
Device
Intervention Name(s)
RD047-023
Intervention Description
Experimental hydrogel
Intervention Type
Device
Intervention Name(s)
Predicate Device
Other Intervention Name(s)
Kelo-Cote
Primary Outcome Measure Information:
Title
Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)
Description
Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
Time Frame
4 weeks, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Pain and itch
Description
Patient assessment of pain and itch. Scoring from 0-3.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Adverse Events
Description
Number of subjects with related adverse events
Time Frame
Baseline, Weeks: 2, 4, 8, 12 and early termination
Title
Treatment satisfaction
Description
Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".
Time Frame
8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet C DuBois, MD
Organizational Affiliation
Derm Research, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
DermResearch Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Substantial Equivalence Study of RD04723 and Predicate Device
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