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

Trial Summary

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 data supports the effectiveness of the treatment Pulsed Dye Laser Therapy for burn scars?

Research shows that Pulsed Dye Laser (PDL) therapy is effective in treating hypertrophic scars, which are thick, raised scars, and can help improve their appearance. It has been used successfully for scars from surgeries and burns, making it a promising option for burn scars as well. ^{1 2 3 4 5}

Is pulsed dye laser therapy safe for treating scars?

Research indicates that pulsed dye laser therapy is generally safe for treating scars, with most people experiencing only temporary redness and bruising. ^{1 2 6 7 8}

How is Pulsed Dye Laser Therapy different from other treatments for burn scars?

Pulsed Dye Laser Therapy (PDL) is unique because it uses a specific wavelength of light to target blood vessels in the skin, which can help reduce redness and improve the appearance of hypertrophic (raised) scars. Unlike some other treatments, PDL is non-invasive and can be precisely controlled to minimize damage to surrounding skin. ^{2 4 9 10 11}

What is the purpose of this trial?

The purpose of this study is to determine the effects (good or bad) of pulsed dye laser treatment in burn scar height, texture, redness and pliability in acute burn injury.

Research Team

S Logsetty, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

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

Fitzpatrick I-III skin type

Patients with burn scar

Scar age one to 6 months

Exclusion Criteria

Patients with established disposition towards keloid scarring

I currently have an active infection.

I currently have an open wound.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

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) 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]

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]

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]

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]

References

1. 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]

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

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

3. United States 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. [2015]

4. United States 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. [2007]

5. Netherlands 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. [2022]

6. 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]

7. 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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Pulsed dye laser in burn scars: current concepts and future directions. [2015]

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

Treatment of vascular skin lesions with the variable-pulse 595 nm pulsed dye laser. [2022]

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

Laser scar revision: comparison of CO2 laser vaporization with and without simultaneous pulsed dye laser treatment. [2019]

11. United States 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. [2022]