What side effects are associated with this type of intervention?

Common treatments for hypertrophic scars, such as silicone gel sheets, corticosteroid injections, laser therapy, and pressure therapy, have various side effects. Silicone gel sheets may cause mild skin irritation. Corticosteroid injections can lead to skin thinning, discoloration, and potential systemic effects. Laser therapy might result in temporary redness, swelling, and changes in skin pigmentation. Pressure therapy can cause discomfort and skin breakdown if not properly managed.

What prior FDA approvals exist?

FDA-approved treatments for hypertrophic scars include silicone gel sheets and corticosteroid injections. Silicone gel sheets, such as those made by brands like Mepiform and Cica-Care, are widely used for their effectiveness in flattening and reducing the redness of scars. Corticosteroid injections, like triamcinolone acetonide, are also commonly used to reduce inflammation and scar size. These treatments are similar to the developmental formulation being studied for its comparative effectiveness to a predicate device in treating hypertrophic and keloid scars.

What other types of research exist?

Promising novel alternatives for treating hypertrophic and keloid scars include: 1) Injectable soft tissue fillers such as hyaluronic acid-based fillers, which have shown effectiveness in tissue augmentation and scar improvement. 2) Stem cell therapy, particularly using bone marrow-derived mesenchymal stem cells, which have demonstrated potential in promoting wound healing and reducing scar formation. 3) Photodynamic therapy, which has been effective in treating various skin conditions and may offer benefits for scar treatment. Patients should discuss these options with their healthcare provider to determine the best course of action based on their specific condition and medical history.

← Back to Search

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

Must not have

History of diabetes

History of collagen vascular disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks: 2, 4, 8, 12 and early termination

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of diabetes.

Select...

I have a history of collagen vascular disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks: 2, 4, 8, 12 and early termination

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)

Secondary study objectives

Adverse Events

Pain and itch

Treatment satisfaction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hypertrophic scars include silicone gel sheets, corticosteroid injections, and laser therapy. Silicone gel sheets work by hydrating the scar tissue and reducing collagen production, which helps flatten and soften the scar. Corticosteroid injections reduce inflammation and collagen synthesis, leading to a decrease in scar size and thickness. Laser therapy remodels the collagen in the scar tissue, improving its appearance and texture. Understanding these mechanisms is important for hypertrophic scar patients as it allows them and their doctors to select the most effective treatment tailored to their specific scar characteristics and personal needs.