DFG Laser vs CO2 Laser for Pain and Wound Healing

Overseen By Abigail Carlson, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Retinoids, Corticosteroids, Hydroquinone, others

Disqualifiers: Pregnancy, Alcohol abuse, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

23 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using certain topical or systemic retinoids, corticosteroids, or other prescription topical medications on the area of interest, you may need to stop as these are part of the exclusion criteria.

What data supports the effectiveness of the DFG Laser vs CO2 Laser treatment for pain and wound healing?

Fractional CO2 lasers have been shown to effectively treat skin issues like scars and photoaging with fewer side effects and quicker recovery compared to traditional methods. This suggests that similar laser treatments, like the DFG Laser, might also be effective for pain and wound healing. ^{1 2 3 4 5}

How does the DFG Laser treatment differ from other treatments for pain and wound healing?

The DFG Laser treatment, which includes fractional CO2 lasers, is unique because it combines fractional photothermolysis (a method that targets small areas of skin) with an ablative wavelength, allowing for effective treatment of scars and skin damage with shorter recovery times and fewer side effects compared to traditional CO2 laser treatments. ^{1 2 3 5 6}

What is the purpose of this trial?

This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime.

Research Team

Dieter Manstein, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for healthy individuals who are interested in participating in a study comparing two types of laser treatments. Specific eligibility criteria have not been provided, so it's best to contact the research team for details.

Inclusion Criteria

Subjects must be in good general health, based on answers provided during the screening visit

Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol

Subjects must be able to read and understand English

Exclusion Criteria

Is not able to follow study protocol

Are pregnant or lactating

Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day [e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks]

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with DFG and CO2 lasers on the upper thighs. Pain scores and OCT imaging are recorded.

1 month

Multiple visits for photography, pain score assessment, and OCT imaging

Follow-up

Participants are monitored for wound healing and dermal vasculature changes using OCT imaging

1 month

Treatment Details

Interventions

• CO2 Laser
• DFG Laser

Trial Overview The study is testing pain levels and wound healing after using two different lasers: DFG Laser and CO2 Laser. It also uses Optical coherence tomography (OCT) to get detailed images of the skin.

Participant Groups

Group I: Treatment Experimental Treatment 3 Interventions

23 healthy subjects with treatment of the DFG and CO2 laser

CO2 Laser is already approved in United States, European Union for the following indications:

Approved in United States as CO2 Laser for:

• Scleroderma-induced microstomia
• Various skin conditions

Approved in European Union as CO2 Laser for:

• Scleroderma-induced microstomia
• Various skin conditions

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Fractionated CO(2) lasers are effective for skin resurfacing, particularly in treating facial photoaging and scars.

These lasers offer a better safety and recovery profile compared to traditional CO(2) laser treatments, making them a preferable option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional CO(2) laser resurfacing. Carniol, PJ., Harirchian, S., Kelly, E.[2017]

A retrospective study of 490 fractional CO2 laser treatments in 374 patients showed that this method has a low incidence of adverse events (13.6%), making it a safe option for treating skin issues like wrinkles and scars.

The most common side effects included acneiform eruptions and herpes simplex outbreaks, but there were no reports of scarring or hypopigmentation, indicating a favorable safety profile compared to traditional laser treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adverse events of deep fractional CO(2): a retrospective study of 490 treatments in 374 patients. Shamsaldeen, O., Peterson, JD., Goldman, MP.[2011]

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 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]

Fractionated CO(2) laser resurfacing effectively treats wrinkles, sun damage, and scars while offering shorter recovery times and fewer side effects compared to traditional CO(2) laser treatments.

This technique utilizes fractional photothermolysis with a 10,600-nm wavelength, expanding its applications and improving patient outcomes in skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated CO2 laser resurfacing: our experience with more than 2000 treatments. Hunzeker, CM., Weiss, ET., Geronemus, RG.[2016]

Ablative fractional CO2 laser treatments, while generally effective and with reduced downtime compared to traditional methods, can lead to hypertrophic scarring, as evidenced by two detailed cases involving neck treatments.

Histopathological analysis confirmed the presence of hypertrophic scars in one patient, highlighting the need for careful post-operative wound care and caution when using this treatment on sensitive areas like the neck.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertrophic scarring of the neck following ablative fractional carbon dioxide laser resurfacing. Avram, MM., Tope, WD., Yu, T., et al.[2021]

References

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

Fractional CO(2) laser resurfacing. [2017]

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

The adverse events of deep fractional CO(2): a retrospective study of 490 treatments in 374 patients. [2011]

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

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

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

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

5. England pubmed.ncbi.nlm.nih.gov

Fractionated CO2 laser resurfacing: our experience with more than 2000 treatments. [2016]

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

Hypertrophic scarring of the neck following ablative fractional carbon dioxide laser resurfacing. [2021]