Pulsed Dye Laser Therapy for Burn Scars

Overseen By Justin P Gawaziuk, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Steroid, Interferon

Disqualifiers: Open wound, Active infection, Keloid, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how pulsed dye laser therapy affects burn scars, focusing on changes in scar height, texture, redness, and flexibility. It compares different parts of the scar, either closer to or farther from the heart. Individuals with burn scars between one to six months old, residing in Winnipeg, and having lighter skin tones (Fitzpatrick I-III), may be suitable candidates. However, if the scar is open, infected, or previously treated, this trial may not be appropriate. As an unphased study, this trial provides a unique opportunity to contribute to understanding how this therapy can improve burn scars.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that pulsed dye laser therapy is safe for treating burn scars?

Research has shown that pulsed dye laser therapy is generally safe for treating scars. One study on burn scars found this laser treatment both safe and effective, with a low dropout rate of 9.8%, indicating good participant tolerance. Another study found that early use of pulsed dye laser can prevent problematic scars from developing without worsening any condition. These studies noted no serious side effects. Overall, pulsed dye laser therapy appears well-tolerated for skin treatments, with few negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Pulsed Dye Laser Therapy is unique because it uses a specific wavelength of light to target and reduce the redness and thickness of burn scars. Unlike traditional treatments like silicone gel sheets or corticosteroid injections, which often take longer to show visible improvement, this laser therapy can provide noticeable changes in a shorter time frame. Researchers are excited about its precision in targeting blood vessels without damaging surrounding tissue, which could lead to more effective and quicker healing for burn scars.

What evidence suggests that pulsed dye laser therapy is effective for burn scars?

Research has shown that pulsed dye laser therapy effectively treats burn scars. Studies have found that this treatment can improve the appearance of scars by reducing redness, lowering their height, and enhancing their texture. One report found that all scars treated with a specific type of pulsed dye laser showed improvement. Another study noted that this laser therapy is safe and effective for thickened burn scars. In this trial, participants will receive pulsed dye laser therapy on different parts of their scars, either proximal or distal to the heart, to evaluate its effectiveness. Overall, evidence supports that pulsed dye laser therapy can help make burn scars less red and smoother. ^{1 2 3 4 6}

Who Is on the Research Team?

S Logsetty, MD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for individuals with skin types Fitzpatrick I-III who have burn scars aged one to six months and live in Winnipeg. It's not suitable for those with open wounds, active infections, prior steroid or interferon scar treatments, or a tendency towards keloid scarring.

Inclusion Criteria

Patients with burn scar

Scar age one to 6 months

Fitzpatrick I-III skin type

Exclusion Criteria

Patients with established disposition towards keloid scarring

I currently have an active infection.

I currently have an open wound.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pulsed dye laser therapy to assess its effects on burn scar height, texture, vascularity, and pliability

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pulsed Dye Laser Therapy

Trial Overview The study is examining the effectiveness of pulsed dye laser therapy on improving the height, texture, redness, and pliability of acute burn scars.

How Is the Trial Designed?

Group I: Proximal Active Control 1 Intervention

part of scar proximal to heart

Group II: Distal Active Control 1 Intervention

part of scar distal to heart

Pulsed Dye Laser Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Pulsed Dye Laser Therapy for:

• Port wine stains
• Hemangiomas
• Rosacea
• Telangiectasias
• Keloids
• Hypertrophic scars
• Acne scars
• Burn scars

Approved in European Union as Pulsed Dye Laser Therapy for:

• Port wine stains
• Hemangiomas
• Rosacea
• Telangiectasias
• Keloids
• Hypertrophic scars
• Acne scars
• Burn scars

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

A study involving 20 patients demonstrated that using a high-energy, pulsed CO2 laser significantly improves nonerythematous hypertrophic scars, especially when combined with a 585-nm pulsed dye laser (PDL).

The combination treatment showed greater improvement in scar appearance compared to using the CO2 laser alone, highlighting the effectiveness of the PDL's vascular targeting in enhancing scar revision outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser scar revision: comparison of CO2 laser vaporization with and without simultaneous pulsed dye laser treatment. Alster, TS., Lewis, AB., Rosenbach, A.[2019]

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]

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]

In a study involving 19 patients with keloidal or hypertrophic scars, a pulse width of 0.45 ms from a 595-nm pulsed dye laser (PDL) was found to be significantly more effective than a 40 ms pulse width in reducing scar size and improving pliability after three treatments.

Both pulse widths resulted in significant volume reduction of the scars, but the 0.45 ms treatment also led to better elasticity, while neither pulse width significantly affected scar erythema, indicating that the shorter pulse width may provide a more favorable outcome for scar treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of pulse width of a 595-nm flashlamp-pumped pulsed dye laser on the treatment response of keloidal and hypertrophic sternotomy scars. Manuskiatti, W., Wanitphakdeedecha, R., Fitzpatrick, RE.[2022]

In a study involving 20 patients with erythematous surgical scars, both the 532-nm KTP laser and the 595-nm PDL laser showed clinical improvement without significant differences in overall efficacy or safety, indicating both are effective treatment options.

The KTP laser specifically demonstrated a statistically significant improvement in the vascularity component of scar assessment, while side effects were minimal and included only mild discomfort and transient redness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 532 nm Potassium Titanyl Phosphate Laser and 595 nm Pulsed Dye Laser in the Treatment of Erythematous Surgical Scars: A Randomized, Controlled, Open-Label Study. Keaney, TC., Tanzi, E., Alster, T.[2015]

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]

In a study of 239 Korean patients with vascular skin lesions treated with variable-pulse 595 nm pulsed dye lasers, 51.9% achieved good to excellent clearance, demonstrating the efficacy of this treatment in darker skin types.

Treatment outcomes varied by lesion type, with 78.0% of patients with telangiectasia showing good to excellent results, while factors like lesion location and patient age influenced the effectiveness, particularly for hemangiomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of vascular skin lesions with the variable-pulse 595 nm pulsed dye laser. Woo, SH., Ahn, HH., Kim, SN., et al.[2022]

In a study involving 10 patients with keloidal or hypertrophic scars, treatment with a 585-nm pulsed-dye laser (PDL) showed significant improvements in scar height, erythema, and pliability after multiple sessions, with noticeable results as early as 16 weeks.

The study found no significant difference in treatment outcomes based on the energy density (fluence) of the laser (3, 5, or 7 J/cm²), although lower fluences tended to show better improvement, suggesting that more treatment sessions may enhance scar resolution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy density and numbers of treatment affect response of keloidal and hypertrophic sternotomy scars to the 585-nm flashlamp-pumped pulsed-dye laser. Manuskiatti, W., Fitzpatrick, RE., Goldman, MP.[2007]

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]

The pulsed dye laser (PDL) has proven to be an effective treatment for hypertrophic burn scars, significantly reducing scar redness, thickness, and itchiness while improving cosmetic appearance, based on over 10 years of clinical experience.

Using PDL as a treatment option can reduce the need for excisional surgery, which often carries risks of complications and deformities, making it a safer alternative for managing difficult scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed dye laser in burn scars: current concepts and future directions. Parrett, BM., Donelan, MB.[2015]

Pulsed Dye Laser (PDL) shows promise as an effective therapeutic tool for both the prevention and treatment of hypertrophic burn scars, with a focus on the importance of early intervention.

The review suggests that future research should include a prospective randomized controlled study using 595 nm PDL specifically for preventing scars that are less than 6 months old, highlighting the need for timely treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention or treatment of hypertrophic burn scarring: a review of when and how to treat with the pulsed dye laser. Brewin, MP., Lister, TS.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11032680/

Very Early Pulsed Dye Laser Intervention for Optimal ... The total Vancouver Scar Scale score significantly reduced after treatment in all groups. The Vancouver Scar Scale score reduction rate was ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0305417925001299

Early Laser for Burn Scars (ELABS) Pulsed dye laser treatment is safe and effective for hypertrophic burn scarring. •. This study had a low attrition rate of 9.8 %. •. Pulsed dye laser should ...

3. candelamedical.com candelamedical.com/products/vbeam-pulsed-dye-laser/

Vbeam® Pulsed-Dye Laser (PDL) Machine One report found that all scars treated with a Vbeam 595 nm pulsed dye laser significantly improved in appearance. ... Rating the burn scar. J Burn Care Rehabil.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jocd.70053

Efficiency of Early Sequential Laser Treatment for Facial ... Early sequential treatment with PDL and CO 2 -AFL demonstrates significant effectiveness in improving long linear scars across various facial regions.

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

Pulsed Dye Laser Treatment - Medical Clinical Policy ... The authors concluded that PDL is a safe and potentially promising treatment for established vocal fold scar. Subjectively, no patients were worse and 10 of 11 ...

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

Clinical Efficacy and Safety of Pulsed Dye Laser Combined ... This research analyzed the clinical effectiveness and safety of pulsed dye laser (PDL) combined with pingyangmycin (PI) in the treatment of post-acne HS.