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

28 Participants Needed

Trial Summary

What is the purpose of this trial?

Hypertrophic Burn Scars (HTBS) are often treated with Fractional CO2 laser therapy to improve cosmetic appearance. It has been noted that this leads to a reduction in the pain and itch associated with this type of scars. While this phenomenon is commonly described in the literature, the mechanism of pain and itch reduction in unclear. The investigators aim to better understand this process by histological evaluation of HTBS at different stages of laser treatment.

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 data supports the effectiveness of the treatment Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser for burn scars?

Research shows that fractional carbon dioxide laser treatment significantly improves the appearance and texture of mature burn scars, with patients reporting a 44.44% improvement in their overall assessment of their scars. The treatment also enhances the arrangement and amount of collagen and elastic fibers in the skin, contributing to better scar relief and pliability. ^{1 2 3 4 5}

Is the Fractional CO2 Laser generally safe for humans?

The Fractional CO2 Laser is generally considered safe for treating scars and other skin conditions, but some side effects have been reported, such as skin discoloration and prolonged healing time. It's important to discuss potential risks with your doctor, especially if you have had previous treatments like silver-impregnated dressings. ^{1 2 3 6 7}

How is the Luminis Ultrapulse Fractional CO2 Laser treatment different from other treatments for burn scars?

The Luminis Ultrapulse Fractional CO2 Laser is unique because it uses a specialized laser that can target scars with precision, offering both non-sequential and sequential scanning options to improve scar appearance. This method is different from traditional treatments like dermabrasion, as it allows for more controlled and effective resurfacing of the skin. ^{1 2 6 8 9}

Research Team

Jonathan Friedstat, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

Not be pregnant or planning to become pregnant during the treatment phase of the study

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

References

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

Dystrophic calcification and accentuated localized Argyria after fractionated carbon dioxide laser therapy of hypertrophic scars. [2016]

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

Ultrapulsed fractional CO2 laser for the treatment of post-traumatic and pathological scars. [2012]

3. China 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]. [2018]

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

Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Mature Burn Scars: A Clinical, Histopathological, and Histochemical Study. [2020]

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

Fractional CO2 laser to improve noticeable scars after skin cancer surgery: An appraisal by the patients, laypersons, and experts. [2022]

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

Ultrapulse-mode versus superpulse-mode fractional carbon dioxide laser on normal back skin. [2016]

7. England pubmed.ncbi.nlm.nih.gov

A randomized guinea pig study on external cell growth factors after fractional ultrapulsed CO(2) laser therapy. [2013]

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

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. [2022]

9. United States 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. [2015]