A Substantial Equivalence Study of RD04723 and Predicate Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|