Overview

This trial is active, not recruiting.

Conditions hypertrophic scar, keloid scar
Treatments rd047-023, predicate device
Sponsor Oculus Innovative Sciences, Inc.
Start date August 2012
End date March 2013
Trial size 40 participants
Trial identifier NCT01736969, MSM-RD-023

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
RD-047-023
rd047-023
Experimental hydrogel
(Active Comparator)
legally marketed predicate device
predicate device Kelo-Cote

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Pain and itch
time frame: 4 weeks, 8 weeks, 12 weeks
Adverse Events
time frame: Baseline, Weeks: 2, 4, 8, 12 and early termination
Treatment satisfaction
time frame: 8 weeks, 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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)

Additional Information

Official title Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
Principal investigator Janet C DuBois, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Oculus Innovative Sciences, Inc..