Laser Therapy for Burn Scars

Overseen By Justin Gawaziuk, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Open wound

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 15 weeks

6 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment for burn scars?

Research shows that fractional CO2 laser therapy significantly improves burn scars by reducing scar firmness and improving surface texture, with noticeable results after just one treatment session. Patients also report high satisfaction with the treatment, indicating its effectiveness in improving the appearance and quality of life for those with burn scars. ^{1 2 3 4 5}

Is laser therapy safe for treating burn scars?

Laser therapy, specifically Fractional CO2 Laser, is generally safe for treating burn scars, with minimal adverse events reported. In a study of 544 treatments, only 2.4% experienced minor issues like increased pain, numbness, redness, or blistering, and most patients saw improvements in their scars. ^{4 5 6 7 8}

How is Fractional Vascular Laser Therapy different from other treatments for burn scars?

Fractional Vascular Laser Therapy, specifically using a Fractional CO2 Laser, is unique because it offers pronounced clinical outcomes with fewer treatment sessions compared to nonablative lasers. It works by creating controlled thermal damage, which helps remodel the scar tissue and improve its appearance, making it a novel option for treating burn scars. ^{3 4 5 9 10}

What is the purpose of this trial?

While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our assessing the effects of fractional vascular lasers on burn scars. It has been hypothesized that the fractional vascular lasers work on mature scars to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the mesh pattern created by meshed split thickness skin graft). Objective: To determine the benefit of fractional vascular laser treatment in improving burn scar height, texture, vascularity and pliability in late burn scars.

Research Team

S Logsetty, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for individuals with burn scars that are 6-12 months old, located on the trunk or limbs. Participants should have a Fitzpatrick skin type I-III and must live in Winnipeg. People with open wounds cannot participate.

Inclusion Criteria

Thermal burn scar on trunk or extremities

Fitzpatrick skin type I-III

Living in Winnipeg

Exclusion Criteria

I have an open wound.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional vascular laser treatment to improve burn scar height, texture, vascularity, and pliability

15 weeks

5 visits (every 3 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fractional Vascular Laser

Trial Overview The study is testing fractional vascular laser therapy to see if it can improve the height, texture, vascularity, and pliability of mature burn scars. It's a randomized controlled trial aiming to provide conclusive evidence about the effectiveness of this expensive treatment.

Participant Groups

Group I: Distal Experimental Treatment 1 Intervention

location of scar distal to heart

Group II: Proximal Active Control 1 Intervention

location of the scar proximal to heart

Fractional Vascular Laser is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fractional CO2 Laser for:

• Burn scars
• Hypertrophic scars
• Keloid scars

Approved in European Union as Fractional Ablative Laser for:

• Burn scars
• Hypertrophic scars
• Atrophic scars

Approved in Canada as Fractional Vascular Laser Therapy for:

• Burn scars
• Late burn scars
• Mature scars

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Findings from Research

Fractional ablative carbon dioxide laser therapy is a safe and effective treatment for hypertrophic burn scars, showing significant improvements in scar appearance and quality of life after just one session in a study of 10 patients.

After 6 months, patients experienced notable reductions in scar firmness and surface relief, with improvements measured by various clinical scales, indicating that while more sessions may be needed for optimal results, even a single treatment can lead to meaningful changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrapulsed fractional ablative carbon dioxide laser treatment of hypertrophic burn scars: evaluation of an in-patient controlled, standardized treatment approach. Poetschke, J., Dornseifer, U., Clementoni, MT., et al.[2019]

A survey of 64 burn patients treated with the Erbium-Yag laser showed that 94% reported some degree of improvement in their scars, with an average satisfaction score of 8.3 out of 10.

The treatment significantly reduced symptoms associated with scars, such as pain and itching, indicating that fractional laser therapy is an effective option for improving burn scar characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction after fractional ablation of burn scar with 2940nm wavelength Erbium-Yag laser. Madni, TD., Nakonezny, PA., Imran, JB., et al.[2022]

A multicenter study involving 29 subjects with hypertrophic burn scars demonstrated that fractional ablative CO2 laser treatment significantly improved the elasticity, thickness, and overall appearance of scars, with objective measures showing improvements at a statistically significant level (P < 0.01).

Patient-reported outcomes also indicated significant reductions in pain and pruritus, and these improvements were sustained for at least 6 months after the treatment, highlighting the efficacy and lasting benefits of this laser therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Miletta, N., Siwy, K., Hivnor, C., et al.[2022]

In a double-blind clinical trial involving 10 patients with burn scars, the combination of stromal vascular fraction (SVF) injection and fractional CO2 laser treatment showed significantly better improvements in scar appearance and patient satisfaction compared to fractional CO2 laser treatment alone.

The study demonstrated that the combination therapy not only improved the Vancouver scar scale scores but also enhanced skin density and epidermal thickness, suggesting that SVF may enhance the regenerative effects of the laser treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of fractional CO2 laser in combination with stromal vascular fraction (SVF) compared with fractional CO2 laser alone in the treatment of burn scars: a randomized controlled clinical trial. Roohaninasab, M., Khodadad, F., Sadeghzadeh-Bazargan, A., et al.[2023]

In a study involving 11 patients with burn scars, treatment with fractional CO2 laser resulted in significant clinical improvement, as measured by the Vancouver scar scale, indicating its efficacy in scar reduction.

Histological analysis revealed that the treatment promoted the formation of new collagen fibers in the upper dermis, leading to smoother skin and improved tension, although some patients experienced postinflammatory hyperpigmentation and itching as side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal Remodeling of Burn Scar by Fractional CO2 Laser. Lee, SJ., Suh, DH., Lee, JM., et al.[2017]

Ablative fractional CO2 laser treatment is safe and effective for improving hypertrophic burn scars, with significant reductions in scar severity observed even when treatment is initiated within 1 month after injury.

The study involved 221 patients and found that both early (within 3 months) and late (more than 12 months) treatments resulted in decreased hardness and redness of scars, indicating that early intervention can be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertrophic Scar Improvement by Early Intervention With Ablative Fractional Carbon Dioxide Laser Treatment. Tan, J., Zhou, J., Huang, L., et al.[2021]

In a study of 170 burn patients undergoing fractional CO2 laser therapy for hypertrophic scars, only 2.4% of treatment sessions resulted in adverse events, indicating that this therapy is generally safe.

Despite some minor side effects like increased pain and erythema, 97.1% of patients reported improvements in their scar symptoms, highlighting the efficacy of fractional CO2 laser therapy in managing hypertrophic burn scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. Won, P., Cooper, M., Gillenwater, TJ., et al.[2023]

Fractional carbon dioxide laser treatment significantly improved the quality of postburn scars in patients with skin phototypes III to VI, with average scores increasing from 4.4 to 7.33 for physicians and from 5.35 to 7.5 for patients after one year.

While 60% of patients experienced mild hypochromia two months post-treatment, this decreased to only 15% after one year, indicating that while hypopigmentation can occur, it often resolves over time, especially in patients with darker skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up. Salles, AG., Luitgards, BF., Moraes, LB., et al.[2021]

Fractional CO2 laser procedures are safe and effective for skin rejuvenation and scar management, allowing for customized treatments based on individual skin features.

Very short-pulse-duration devices can provide significant improvements in scar tissue by inducing controlled thermal damage, leading to immediate relaxation of tension and long-term skin remodeling through molecular activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Developments for Fractional Co2 Resurfacing for Skin Rejuvenation and Scar Reduction. Clementoni, MT., Pedrelli, V., Zaccaria, G., et al.[2020]

Fractional CO2 laser treatment significantly improves burn scars, as evidenced by reductions in scores on various scar assessment scales, including the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale, across 14 studies.

The therapy not only enhances the appearance of scars by improving pigmentation, vascularity, pliability, and height, but also alleviates associated symptoms like pain and itching, making it a valuable option for scar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of fractional carbon dioxide laser therapy for burn scars: a meta-analysis. Zhang, C., Yin, K., Shen, YM.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Ultrapulsed fractional ablative carbon dioxide laser treatment of hypertrophic burn scars: evaluation of an in-patient controlled, standardized treatment approach. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Patient satisfaction after fractional ablation of burn scar with 2940nm wavelength Erbium-Yag laser. [2022]

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

Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of fractional CO2 laser in combination with stromal vascular fraction (SVF) compared with fractional CO2 laser alone in the treatment of burn scars: a randomized controlled clinical trial. [2023]

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

Dermal Remodeling of Burn Scar by Fractional CO2 Laser. [2017]

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

Hypertrophic Scar Improvement by Early Intervention With Ablative Fractional Carbon Dioxide Laser Treatment. [2021]

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

Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. [2023]

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

Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up. [2021]

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

New Developments for Fractional Co2 Resurfacing for Skin Rejuvenation and Scar Reduction. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of fractional carbon dioxide laser therapy for burn scars: a meta-analysis. [2022]