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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using lasers to improve the appearance of scars after surgery. Researchers aim to determine if two types of lasers, the pulsed dye laser (PDL) and the fractional photothermolysis laser, can enhance scar appearance. In one part of the study, participants may choose to receive the treatment, while in another part, they might be randomly assigned to either receive the treatment or not. Individuals who have undergone surgery on their body or limbs and reside in the Chicago area might be suitable candidates, especially if they have recently had stitches removed. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative scar treatment research.

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 prior data suggests that this procedure is safe for cosmetic improvement of post-surgical scars?

Research has shown that using Pulsed Dye Laser (PDL) with Fractional Photothermolysis is generally safe for treating scars. In past studies, patients handled this combination well, with no serious problems reported. One study found that 96.67% of participants were very satisfied, indicating that the treatment is both safe and effective. Another study confirmed that this treatment improves the look and feel of scars without causing any lasting harm or recurrence. Overall, these findings suggest that the treatment is safe and could be a promising option for those wanting to improve the appearance of surgical scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Fractional Photothermolysis Laser and Pulsed Dye Laser (PDL) for treating scarring because this dual approach offers a unique mechanism. While traditional treatments often focus on either resurfacing the skin or targeting blood vessels individually, this combination can do both simultaneously. Fractional Photothermolysis uses precise laser energy to promote skin regeneration, while PDL specifically targets and reduces redness by shrinking blood vessels. This dual action not only addresses various scar components more comprehensively but also has the potential to enhance overall skin texture and appearance more effectively than standard single-method treatments.

What evidence suggests that this trial's treatments could be effective for improving post-surgical scars?

This trial will compare the use of Pulsed Dye Laser (PDL) and fractional photothermolysis together against a control group. Studies have shown that combining PDL and fractional photothermolysis can enhance the appearance of scars. One study found that this combination treatment made burn scars smoother, improved their color, and enhanced their function, while also reducing itching. Another study showed that PDL alone significantly improved raised and thick scars, while fractional lasers provided additional benefits. In some cases, 66% of patients noticed a clear improvement in their scars after treatment. These findings suggest that using these lasers together could effectively improve the appearance of post-surgical scars. ^{2 3 4 6 7}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417920306318

Effects of combined Pulsed Dye Laser and Fractional CO2 ... Our study clearly shows that combined CO2-AFL treatment for burn scars improve texture, colour, function and alleviate pruritus.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5561714/

Fractional Carbon Dioxide, Long Pulse Nd:YAG and ... In 2004, Chan et al.[22] treated 36 scars in 27 patients with 585 nm – PDL and 66% reported clinical improvement which is slightly less than that of our study ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00685243

Study Details | NCT00685243 | Treatment of Surgical Scars ... Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of surgical scars, both in terms of pigmentary and textural changes.

4. withpower.com withpower.com/trial/phase-2-2017-32728

PDL + Fractional Photothermolysis for Scarring The pulsed dye laser (PDL) treatment significantly improved hypertrophic scars in 19 post-thyroidectomy patients, as measured by the Vancouver Scar Scale and ...

5. academic.oup.com academic.oup.com/jbcr/article-abstract/40/Supplement_1/S37/5371966

Results from a Large, Rater-Blinded, before-after Cohort Study In this rater-blinded, before-after cohort study, PDL significantly improved objective measures of hypertrophic burn scars, but fCO2 lasers significantly ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9441375/

Clinical Efficacy and Safety of Pulsed Dye Laser Combined ... The research group showed better scar repair, skin improvement, and granulation tissue maturity than the control group. And compared with the ...

7. aetna.com aetna.com/cpb/medical/data/500_599/0559.html

Pulsed Dye Laser Treatment - Medical Clinical Policy ... No scarring was detectable and there was no recurrence in the 9-month follow-up. The authors concluded that GF may be successfully treated with the long-pulsed ...