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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of fractional vascular laser therapy in improving burn scars. The goal is to determine if this laser treatment can make scars flatter, smoother, less red, and more flexible. It targets individuals with burn scars that are 6 to 12 months old, located on the trunk or arms and legs. Participants should reside in Winnipeg and have lighter skin tones, defined as Fitzpatrick skin types I-III. The trial includes two groups: one with scars closer to the heart and another with scars farther from the heart. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future burn scar treatments.

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 prior data suggests that this laser therapy is safe for burn scars?

Research has shown that fractional vascular lasers are generally safe for treating burn scars. Studies have found these lasers effective and well-tolerated. For example, one study found that using a fractional CO2 laser improved scar thickness and symptoms without causing major side effects. Another study reported that fractional laser resurfacing is safe for scars from burns and injuries, indicating that serious problems or complications are rare with this treatment. Overall, evidence suggests that fractional vascular lasers offer a promising option for improving the appearance of burn scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fractional Vascular Laser therapy is unique because it targets burn scars using precise laser technology. Unlike traditional treatments like topical creams or surgical procedures, which often focus on managing symptoms or removing scar tissue, this laser therapy directly affects blood vessels within the scar tissue, potentially improving healing and appearance. Researchers are excited about this method because it offers a non-invasive approach that can be finely tuned to the specific needs of different scar locations, such as distal or proximal areas relative to the heart, promising more personalized and effective outcomes.

What evidence suggests that fractional vascular laser therapy is effective for improving burn scars?

Research has shown that fractional CO2 laser therapy, studied in this trial as Fractional Vascular Laser, can improve burn scars. Studies have found that this treatment smooths scars, reduces their height, and aids in better skin healing. Many patients report less pain and itchiness in their scars after treatment. Although this laser therapy appears promising, more detailed studies are needed to confirm these benefits. The treatment smooths the skin, making scars less noticeable and more flexible. Participants in this trial will receive treatment on scars located either distal or proximal to the heart to evaluate its effectiveness. ^{4 6 7 8 9}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31469749/

Fractional Ablative Laser Therapy is an Effective Treatment ... Background: Fractional CO2 laser treatment has been reported to improve burn scars, with increasing clinical use despite a paucity of controlled ...

2. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-023-03480-8

Efficacy of fractional CO2 laser in combination with stromal ... The results confirm the efficacy of SVF injection in combination with fractional CO 2 laser in the treatment of burn scars and can be considered as a treatment ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417920305751

Fractional CO2 laser treatment for burn scar improvement The objective of this review is to summarize the evidence demonstrating the efficacy of fractional CO2 laser in improving burn scars using validated and ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546018/table/rc1128.app4.tab2/

Fractionated CO2 Laser for Scar Improvement: A Review of ... Patients reported a significant improvement in scar pain (P = 0.047) and itch (P < 0.01) on the POSAS scar score only in the treated areas when compared to pre- ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jocd.16708

Fractional CO2 Laser to Treat Surgical Scars: A System ... However, fractional CO2 laser treatment administered over 3 months after surgery did not significantly improve postoperative scars (MD: –0.17; ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37742019/

Efficacy of fractional CO2 laser in combination with stromal ... The results confirm the efficacy of SVF injection in combination with fractional CO 2 laser in the treatment of burn scars and can be considered as a treatment ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417920305490

Effectiveness and safety of ablative fractional CO2 laser for ... This study demonstrates that AFL-CO 2 is an effective and safe treatment modality for burn scars improving thickness, symptoms and quality of life of burn ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4645146/

Efficacy and Safety of Fractional CO2 Laser Resurfacing in ... Data from our study suggests that fractional laser resurfacing with CO2 laser is a safe and effective treatment option in post-burn and post-traumatic scars.

9. tandfonline.com tandfonline.com/doi/full/10.1080/09546634.2023.2202287

Efficacy and safety of ablative CO2 fractional laser ... Nowadays, ablative fractional CO2 laser treatment has been found to be highly beneficial and safe for the treatment of hypertrophic scars (Citation8–10).