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N/A

RD047-023 for Scars

N/A
Waitlist Available
Led By Janet C DuBois, MD
Research Sponsored by Oculus Innovative Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Negative pregnancy test for women of childbearing potential
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks: 2, 4, 8, 12 and early termination
Awards & highlights

Study Summary

This trial will compare a new medication to an existing one to see if the new one is just as effective in treating scars.

Who is the study for?
This trial is for individuals with hypertrophic or keloid scars that are accessible for treatment. Participants must be able to follow the study's instructions, not be pregnant, agree to use birth control, and provide informed consent. People with diabetes, collagen vascular disorders, planned surgeries during the study period, or a history of allergies to components cannot join.Check my eligibility
What is being tested?
The study is testing whether RD047-023 is as effective as an existing device (the predicate device) in treating hypertrophic and keloid scars. The goal is to see if the new formulation can match the results of the current standard treatment.See study design
What are the potential side effects?
While specific side effects are not detailed here, potential risks may include skin irritation at the site of application or allergic reactions due to sensitivity towards materials used in either RD047-023 or the predicate device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks: 2, 4, 8, 12 and early termination
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks: 2, 4, 8, 12 and early termination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)
Secondary outcome measures
Adverse Events
Pain and itch
Treatment satisfaction

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RD047-023Experimental Treatment1 Intervention
RD-047-023
Group II: Predicate DeviceActive Control1 Intervention
legally marketed predicate device

Find a Location

Who is running the clinical trial?

Oculus Innovative Sciences, Inc.Lead Sponsor
3 Previous Clinical Trials
147 Total Patients Enrolled
Janet C DuBois, MDPrincipal InvestigatorDerm Research, PLLC

Media Library

Predicate Device (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT01736969 — N/A
Hypertrophic Scar Research Study Groups: RD047-023, Predicate Device
Hypertrophic Scar Clinical Trial 2023: Predicate Device Highlights & Side Effects. Trial Name: NCT01736969 — N/A
Predicate Device (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01736969 — N/A
Hypertrophic Scar Patient Testimony for trial: Trial Name: NCT01736969 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots left for this research program?

"According to the information on clinicaltrials.gov, this particular medical trial is not presently enrolling patients. Initially published in August of 2012 and last updated in November of that same year, it does not appear there are any current vacancies for participants; however, 105 other trials currently have openings available."

Answered by AI

Are there any specific qualifications for joining this analysis?

"In order to be considered for this experiment, individuals must display symptoms of hypertrophy and have an age between 18-65. A cap of 40 participants has been set in place by the clinical trial's organisers."

Answered by AI

Is this research encompassing geriatric patients?

"This trial is exclusively for individuals aged 18 to 65. However, there are alternative medical trials available for minors and seniors with 15 and 84 studies respectively."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have a big kiloid on my chest for nearly 20 years.
PatientReceived 2+ prior treatments
~3 spots leftby Mar 2025