What side effects are associated with this type of intervention?

Common treatments for scarring, such as Pulsed Dye Laser (PDL) and Fractional Photothermolysis, can have several side effects. These include erythema (redness), edema (swelling), and discomfort at the treatment site. There is also a risk of pigmentary alterations, blistering, and, in rare cases, granulomatous reactions. Proper technique and post-treatment care can mitigate some of these risks, but patients may still experience temporary changes in skin texture and color.

What prior FDA approvals exist?

The FDA has approved several laser technologies for the treatment of scarring, including pulsed dye lasers (PDL) and fractional photothermolysis. These treatments work by promoting collagen remodeling and reducing scar tissue. PDL is effective in treating vascular scars by targeting blood vessels, while fractional photothermolysis creates microthermal zones that stimulate the skin's natural healing process. Combined use of these technologies has shown promise in clinical trials for improving the appearance of surgical and hypertrophic scars.

What other types of research exist?

Promising novel alternatives for scarring treatment in 2024 include: 1) Intense Pulsed Light (IPL) therapy, which has shown improvements in skin texture and pigmentation. 2) Photodynamic Therapy (PDT) combined with microneedling, which enhances the efficacy of PDT for skin rejuvenation and scar reduction. 3) Infrared lasers with wavelengths between 1000 and 1800 nm, which penetrate deeply and exert nonablative effects in the reticular dermis, promoting collagen remodeling.

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PDL + Fractional Photothermolysis for Scarring

N/A

Waitlist Available

Led By Murad Alam, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Subjects who are unable to understand the protocol or give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two types of lasers to improve the look of scars after surgery. It targets patients with post-surgical scars to see if these lasers can make their scars less noticeable. One laser reduces redness, while the other helps smooth out the skin.

Who is the study for?

This trial is for adults over 18 in good health who have had dermatologic surgery on their trunk or limbs and are healing with a specific type of suture. They must not be pregnant, breastfeeding, prone to severe scarring, or have certain skin infections. Participants should live near Chicago and stop using topical retinoids one week before treatment.

What is being tested?

The study tests the effectiveness of combining two laser treatments (PDL and fractional photothermolysis) on improving the appearance of post-surgical scars. Part A lets subjects choose to receive treatment; Part B randomly assigns them to either get treated or serve as controls in a 2:1 ratio.

What are the potential side effects?

Potential side effects from the laser treatments may include redness, swelling, bruising at the treated area, changes in skin pigmentation, discomfort during the procedure, and rare chances of scarring.

Eligibility Criteria

Exclusion Criteria

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

Select...

I understand the study and can give my consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in score of Patient and Observer Scar Assessment Scale (POSAS)

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: PDL (Pulsed Dye Laser) and Fractional PhotothermolysisExperimental Treatment2 Interventions

Group II: ControlActive Control1 Intervention

0 / 1Eligibility 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

The most common treatments for scarring, such as Pulsed Dye Laser (PDL) and Fractional Photothermolysis, work by promoting collagen remodeling and reducing scar tissue. PDL targets blood vessels within the scar, causing them to coagulate and be reabsorbed by the body, which reduces redness and improves the texture of the scar. Fractional Photothermolysis creates microthermal zones of injury in the skin, stimulating the body's natural healing process and promoting the production of new collagen. This helps to smooth out the scar and improve its appearance. These mechanisms are crucial for scarring patients as they not only improve the aesthetic appearance of scars but also enhance the skin's texture and elasticity, leading to better overall skin health and patient satisfaction.