Fractional CO2 Laser for Burn Scars

Overseen By Domenic Annand, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Steroids, Antihistamines, Opioids, others

Disqualifiers: Epilepsy, Seizure disorder, others

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: Unknown

Duration: 7 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Fractional CO2 laser treatment can reduce pain and itch in hypertrophic burn scars, which are thick, raised scars that form after burns. Researchers aim to understand why this laser treatment helps by examining the scars closely over time. People with burn scars less than two years old, who experience pain or itch, and are already planning to have laser treatment might be good candidates. As an unphased trial, this study offers a unique opportunity for participants to contribute to understanding and improving treatments for burn scars.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking certain medications, especially those that interfere with wound healing, itch, or pain, such as steroids, antihistamines, opioids, and some others.

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

Research has shown that the Luminis Ultrapulse Fractional Ablative CO2 Laser is generally safe and effective for treating burn scars. One study found it thins scars and reduces symptoms, improving patients' quality of life. Another study confirmed its safety and effectiveness for large scars.

Overall, evidence suggests this laser treatment is well-tolerated, with few reports of serious side effects. The treatment uses laser energy to enhance the skin's appearance and texture, offering a promising option for those with thick burn scars seeking relief from pain and itchiness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser for burn scars because it offers a precise, targeted approach to improving skin texture. Unlike traditional treatments like silicone gels or steroid injections that work on the surface or through medication, this laser penetrates deeper layers of the skin to stimulate collagen production. This not only helps in reducing the appearance of scars but might also improve skin elasticity and texture more effectively. Additionally, its fractional technology allows for quicker healing with minimal downtime, which is a significant advantage over more invasive procedures.

What evidence suggests that the Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser is effective for hypertrophic burn scars?

Research has shown that the Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser, which participants in this trial will receive, effectively improves thick burn scars. Studies have found that this laser treatment can reduce scar firmness by about 30% after just one session. It also enhances the appearance and texture of scars, making them less noticeable. Additionally, this treatment reduces scar thickness and improves the quality of life for individuals with these scars. Many patients experience less pain and itching, though the exact reasons remain unclear. Overall, the laser is considered a safe and effective option for treating burn scars. ^{1 2 4 6 7}

Who Is on the Research Team?

Jonathan Friedstat, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with hypertrophic burn scars that are painful, itchy, or hypersensitive. Participants must have had the burn within the last two years and be planning to undergo laser treatment. They should agree to biopsies and a year of follow-up. Pregnant individuals or those on certain medications like steroids, antihistamines, pain relief drugs, or those affecting wound healing cannot join.

Inclusion Criteria

I am planning to have laser treatment for my burn scar.

Patient must be willing and able to participate in the study with a year of follow-up

I am willing to have biopsy procedures.

Exclusion Criteria

Current treatment with other procedures or drugs (experimental or other) in area of interest

I do not have any health issues that prevent me from getting laser treatment.

My study scar is not near areas needing surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo standard treatment with fractional CO2 laser and additional skin biopsies, along with completing Patient Reported Outcome Measure questionnaires

7 months

Multiple visits for laser treatment and assessments

Follow-up

Participants are monitored for histological changes and symptomatic improvement after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser

Trial Overview The study tests how effective Fractional CO2 laser therapy (Luminis ultrapulse) is in reducing pain and itchiness in hypertrophic burn scars. It involves histological evaluations over different stages of treatment to understand the underlying mechanisms behind symptom improvement.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz

Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fractional CO2 Laser for:

• Hypertrophic Burn Scars
• Scar Reconstruction
• Burn Scar Management

Approved in European Union as Fractional CO2 Laser for:

• Burn Scar Treatment
• Scar Resurfacing
• Hypertrophic Scar Management

Approved in Canada as Lumenis UltraPulse for:

• Burn Scar Reconstruction
• Scar Treatment
• Hypertrophic Burn Scar Management

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A study involving 60 patients with severe scars demonstrated that fractional ultrapulsed CO2 laser resurfacing significantly improved skin tone, texture, and appearance compared to classic dermabrasion, indicating its efficacy as a scar treatment.

The CO2 laser treatment was found to be safe, with no major complications reported and only minor transient side effects, making it a favorable option for managing moderate-to-severe scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrapulsed fractional CO2 laser for the treatment of post-traumatic and pathological scars. Cervelli, V., Gentile, P., Spallone, D., et al.[2012]

The combination of ultra pulse carbon dioxide fractional laser with Deep FX or Scaar FX modes significantly improved hypertrophic scars on the face and neck, with Vancouver Scar Scale scores decreasing from 9.4 to 3.1 points after three treatments over six months.

Patient satisfaction was high, with 150 out of 158 patients reporting they were very satisfied with the treatment, and the procedure had minimal adverse effects, such as mild erythema and temporary pigmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical effects of different modes of ultra pulse carbon dioxide fractional laser used in combination on the treatment of hypertrophic scar on face and neck]. Lei, Y., Li, SF., Yu, YL., et al.[2018]

Ablative fractionated carbon dioxide (fCO2) laser treatment significantly improves the quality and appearance of noticeable scars after skin cancer surgery, as evaluated by patients, laypersons, and experts in a study of 40 patients.

High levels of patient satisfaction were reported following fCO2 laser treatment, indicating its effectiveness and safety as a post-surgical scar management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional CO2 laser to improve noticeable scars after skin cancer surgery: An appraisal by the patients, laypersons, and experts. Wyss, N., Graf, N., Hafner, J., et al.[2022]

In a study involving 10 patients with acne scars, higher-energy, low-density CO2 fractional laser treatment resulted in more significant clinical improvements (over 76%) compared to lower-energy, high-density treatment (51% to 75% improvement).

The findings suggest that using higher fluence settings may be more effective for treating acne scars and enlarged pores, although further research is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-fluence, higher-density versus higher-fluence, lower-density treatment with a 10,600-nm carbon dioxide fractional laser system: a split-face, evaluator-blinded study. Jung, JY., Lee, JH., Ryu, DJ., et al.[2015]

Ablative carbon dioxide fractional laser treatment applied 2 to 3 weeks after thyroid surgery significantly improved the appearance of scars, as indicated by lower Vancouver Scar Scale scores in 23 women.

The treatment was found to be both effective and safe, with 12 out of 23 participants showing over 51% clinical improvement in scar appearance three months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. Jung, JY., Jeong, JJ., Roh, HJ., et al.[2022]

In a study involving 20 male guinea pigs, the use of external cell growth factors after Fractional Ultrapulsed CO2 laser therapy significantly accelerated wound healing compared to a control group.

The combination of recombinant human Epidermal Growth Factor (rhEGF) and recombinant basic Fibroblast Growth Factor (rb-bFGF) was particularly effective, improving skin flexibility and increasing the number of fibroblasts, suggesting a promising approach for enhancing recovery in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized guinea pig study on external cell growth factors after fractional ultrapulsed CO(2) laser therapy. Ai, JJ., Zha, WF., Guo, B., et al.[2013]

In a study involving 20 patients with mature burn scars, treatment with fractional carbon dioxide laser over three sessions led to significant improvements in scar appearance, as measured by the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale (p<0.001).

The treatment was found to be safe, with only mild and tolerable side effects, and resulted in notable improvements in collagen and elastic fiber structure, indicating effective skin remodeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Mature Burn Scars: A Clinical, Histopathological, and Histochemical Study. El-Hoshy, K., Abdel-Halim, MRE., Dorgham, D., et al.[2020]

Ultrapulsed CO2 laser therapy, while effective for treating scars, can lead to unique complications in patients with a history of silver-impregnated dressings, such as worsening hyperpigmentation and the development of pseudo-ochronotic fibers.

A biopsy after treatment revealed dystrophic calcification associated with the laser treatment, indicating that prior silver exposure may influence the outcomes of CO2 laser therapy, highlighting the need for careful patient history assessment before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dystrophic calcification and accentuated localized Argyria after fractionated carbon dioxide laser therapy of hypertrophic scars. Shaub, AR., Brown, PJ., Kobayashi, TT., et al.[2016]

In a study involving seven healthy Chinese women, both ultrapulse-mode (UPCO2) and superpulse-mode (SPCO2) fractional carbon dioxide lasers showed similar clinical outcomes and side effects when treating skin, indicating that both methods are equally effective for skin rejuvenation.

Histological evaluations and imaging techniques revealed that both laser modes effectively stimulated collagen and elastin synthesis, with no significant differences in skin penetration depth or overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrapulse-mode versus superpulse-mode fractional carbon dioxide laser on normal back skin. Xu, XG., Gao, XH., Li, YH., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8971167/

Effects of multiple modes of UltraPulse fractional CO2 laser ... This study demonstrates the safety and efficiency of UltraPulse fractional CO 2 laser treatment for extensive scarring.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11922416/

Assessment of ultra-pulse CO2 laser therapy in ... Sequential laser therapy improves the clinical efficacy for early proliferative burn scars, enhancing scar characteristics overall. When ...

3. laserplast.org laserplast.org/wp-content/uploads/Ultrapulse_CO2_on_burn_scars_gauglitz_potschke.pdf

Ultrapulsed fractional ablative carbon dioxide laser ... Scar firmness in treated scars could be reduced by 30% after one treatment session, as R0 improved by. 0.0797 mm (+30.38%) (p = 0.0212). Fractional ablative.

4. 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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.13850

Fractional ablative carbon dioxide laser treatment of facial ... The aim of this study was to analyze whether ablative fractional carbon dioxide laser (CO2-AFL) treatment can positively influence facial scarring and quality ...

6. doc.uhealthplan.utah.edu doc.uhealthplan.utah.edu/medicalpolicy/mp-060.pdf

CO2 (Carbon Dioxide) Fractional Ablative Laser Treatment ... There is an overall low-quality body of evidence suggesting that ablative FLT with a carbon dioxide (CO2) laser appears reasonably safe and may result in.

7. lumenis.com lumenis.com/aesthetics/products/ultrapulse/

UltraPulse: Co2 Ablative Laser For Skin Resurfacing Ablative skin resurfacing procedures use lasers to reduce the signs of aging, improve skin texture, laxity and tone, and reduce scars and stretch marks.