NCT01736969UnknownNot Applicable
Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
Oculus Innovative Sciences, Inc.1 site in 1 country40 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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)
Arms & Interventions
RD047-023
Experimental
RD-047-023
Intervention: RD047-023 (Device)
Predicate Device
Active Comparator
legally marketed predicate device
Intervention: Predicate Device (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Pain and itch(4 weeks, 8 weeks, 12 weeks)
- Adverse Events(Baseline, Weeks: 2, 4, 8, 12 and early termination)
- Treatment satisfaction(8 weeks, 12 weeks)
Investigators
Study Sites (1)
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