PDL + Fractional Photothermolysis for Scarring

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Herpes simplex, Hypertrophic scars, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 visits

76 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that if you are using topical retinoids (a type of skin treatment), you must stop using them one week before the treatment. For other medications, the protocol does not specify any requirements.

What data supports the effectiveness of the treatment PDL + Fractional Photothermolysis for Scarring?

Research shows that using pulsed dye laser (PDL) combined with fractional CO2 laser can effectively reduce the appearance of burn scars and improve surgical scars. Studies have reported improvements in scar redness and itchiness, indicating that this combination treatment can be beneficial for scar management. ^{1 2 3 4 5}

Is PDL and fractional photothermolysis safe for treating scars?

PDL (Pulsed Dye Laser) is generally considered safe for treating scars, with most people experiencing only temporary redness and bruising. However, rare side effects like scarring and skin color changes have been reported. Combining PDL with fractional CO2 laser is being studied for safety and effectiveness in treating scars. ^{1 3 6 7 8}

How does the PDL + Fractional Photothermolysis treatment for scarring differ from other treatments?

This treatment combines pulsed dye laser (PDL) and fractional CO2 laser, which is unique because it targets both the blood vessels and the skin's surface to reduce scar redness and thickness. This dual approach may offer more effective results compared to using each laser alone. ^{1 3 4 9 10}

What is the purpose of this trial?

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.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

I had skin surgery on my body or limbs with stitches that were removed in 2-3 weeks.

I will stop using topical retinoids one week before treatment.

I can understand and agree to participate in the study.

Exclusion Criteria

I understand the study and can give my consent.

Subjects with a history of hypertrophic scars or keloids

Pregnant or breast feeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive early combined PDL and fractional photothermolysis for cosmetic improvement of post-surgical scars

6 visits

1 standard of care suture removal visit, 3 treatment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 follow-up visits

Treatment Details

Interventions

• Fractional Photothermolysis Laser
• PDL (Pulsed Dye Laser)

Trial Overview 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.

Participant Groups

Group I: PDL (Pulsed Dye Laser) and Fractional Photothermolysis Experimental Treatment 2 Interventions

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

A study involving 60 pediatric patients demonstrated that combining pulsed dye laser (PDL) and fractional CO2 laser treatments significantly improved burn scar conditions, as measured by the Patient and Observer Scar Assessment Scale (POSAS), with all indices showing marked improvement after 6 months (p < 0.05).

The treatment was well-tolerated, with a high satisfaction rate of 96.67% among parents and no severe complications or aggravation of scars reported, indicating both safety and efficacy for this combined laser approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of pulsed dye laser combined with fractional CO2 laser in the treatment of pediatric burn scars. Liu, XJ., Lei, Y., Gold, MH., et al.[2023]

In a study comparing pulsed-dye laser (PDL) treatment combined with compression therapy (CT) to CT alone in burn scar reconstruction, PDL showed significant improvements in scar characteristics, including reduced redness and height, and increased tissue elasticity after just two or three treatments.

The Vancouver Scar Scale (VSS) indicated that PDL plus CT resulted in better overall scar quality, including improvements in vascularity, pliability, pigmentation, and height compared to CT alone, suggesting that PDL is an effective adjunctive therapy for managing burn scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal quantitative analysis of early pulsed-dye laser treatment of scars at a pediatric burn hospital. Bailey, JK., Burkes, SA., Visscher, MO., et al.[2012]

The pulsed dye laser (PDL) treatment significantly improved hypertrophic scars in 19 post-thyroidectomy patients, as measured by the Vancouver Scar Scale and three-dimensional imaging, showing reductions in scar height, vascularity, and pigmentation after eight treatment sessions.

The study suggests a cost-effective treatment protocol using the 595 nm PDL, demonstrating consistent efficacy across multiple assessment methods, with significant improvements noted throughout the treatment course.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study to evaluate the treatment effect of pulsed dye laser on thyroidectomy hypertrophic scars using 3D imaging analysis. Kim, JC., Choi, JW., Kim, YC.[2022]

Pulsed dye laser (PDL) treatment significantly improves surgical scars, as evidenced by decreased Vancouver Scar Scale (VSS) scores in pigmentation, vascularity, pliability, and height across seven randomized controlled trials involving various PDL settings.

PDL is considered safe for most individuals, with only minor side effects like temporary redness and bruising, making it a viable option for scar treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of pulsed dye laser for the treatment of surgical scars: a systematic review and meta-analysis. Cai, Y., Zeng, X., Ying, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of pulsed dye laser combined with fractional CO2 laser in the treatment of pediatric burn scars. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of surgical scars with nonablative fractional laser versus pulsed dye laser: a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Experimental comparative study of the effect of fractional CO2 laser combined with pulsed dye laser versus each laser alone on the treatment of hypertrophic scar of rabbit ears. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Multimodal quantitative analysis of early pulsed-dye laser treatment of scars at a pediatric burn hospital. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

A prospective study to evaluate the treatment effect of pulsed dye laser on thyroidectomy hypertrophic scars using 3D imaging analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Linear scarring following treatment with a 595-nm pulsed dye laser. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Laser-mediated photodynamic therapy of actinic keratoses. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of pulsed dye laser for the treatment of surgical scars: a systematic review and meta-analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Pulsed dye laser treatment, a review of indications and outcome based on published trials. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Pulsed dye laser and pulsed dye laser-mediated photodynamic therapy in the treatment of dermatologic disorders. [2015]