A Substantial Equivalence Study of RD04723 and Predicate Device
|ClinicalTrials.gov Identifier: NCT01736969|
Recruitment Status : Unknown
Verified November 2012 by Oculus Innovative Sciences, Inc..
Recruitment status was: Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : December 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Scar Keloid Scar||Device: RD047-023 Device: Predicate Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||March 2013|
Active Comparator: Predicate Device
legally marketed predicate device
Device: Predicate Device
Other Name: Kelo-Cote
- 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.
- Pain and itch [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]Patient assessment of pain and itch. Scoring from 0-3.
- Adverse Events [ Time Frame: Baseline, Weeks: 2, 4, 8, 12 and early termination ]Number of subjects with related adverse events
- Treatment satisfaction [ Time Frame: 8 weeks, 12 weeks ]Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736969
|United States, Texas|
|Austin, Texas, United States, 78759|
|Principal Investigator:||Janet C DuBois, MD||DermResearch, Inc|