DFG Laser vs CO2 Laser for Pain and Wound Healing

Overseen By Amelia 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of lasers, the DFG laser (Difference Frequency Generation Laser) and the CO2 laser (Ablative Carbon Dioxide Laser), to determine which reduces side effects and downtime more effectively after treatment. The researchers aim to find a safer, more comfortable option for individuals undergoing laser procedures. They seek healthy adults with no skin conditions or damage, such as scars or sunburns, who can understand and follow the study requirements. Participants will help compare the effects of these lasers to improve future treatments. As an unphased trial, this study offers participants the opportunity to contribute to pioneering research that could enhance the safety and comfort of laser procedures.

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 prior data suggests that these laser treatments are safe?

Research shows that the CO2 laser is generally safe and effective. It is often used for skin treatments, such as reducing scars, and most people tolerate it well. Studies find that side effects are usually mild, including redness and a burning sensation immediately after treatment, which tend to resolve quickly.

For the DFG laser, studies suggest it might be a safer option than the CO2 laser. Research indicates a quicker recovery and fewer side effects. The DFG laser's design may promote faster wound healing and reduce discomfort after the procedure.

Both lasers have shown promise in previous studies, with the DFG laser potentially offering a gentler experience. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the DFG Laser treatment for pain and wound healing because it may offer faster recovery times compared to traditional methods like the CO2 laser. Unlike standard treatments, which often rely heavily on conventional laser techniques, the DFG Laser uses a unique laser technology that could potentially enhance the healing process more efficiently. This innovative approach could lead to improved patient outcomes and reduced downtime, making it a promising option in the field of pain management and wound care.

What evidence suggests that this trial's treatments could be effective for pain and wound healing?

This trial will compare the DFG laser with the CO2 laser for pain and wound healing. Research has shown that the DFG laser, which participants in this trial may receive, might be safer and allow for quicker recovery than the traditional CO2 laser. The DFG laser's smaller treatment area could help wounds heal faster and cause fewer side effects. Early results suggest it might be a better choice for patients seeking less recovery time. Meanwhile, studies have confirmed that the CO2 laser, another treatment option in this trial, is effective and safe for improving scars, especially those from burns or surgery, often leading to high patient satisfaction. Both lasers have shown good results, but the DFG laser may offer benefits like fewer side effects and faster healing. ^{2 6 7 8 9}

Who Is on the Research Team?

Dieter Manstein, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. 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 ...

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

Fractional CO2 Laser to Treat Surgical Scars: A System ... Both in RCT and non-RCT settings, fractional CO2 laser therapy exhibited the same efficacious outcomes, with MD values of −0.63 (95% CI: −1.15 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11497552/

Efficacy of fractional carbon dioxide laser-assisted drug ... Our study has demonstrated that fractional CO2 LADD seems to be an encouraging approach in the management of post-burn scars with good patient satisfaction.

4. liebertpub.com liebertpub.com/doi/10.1089/wound.2024.0213

Treatment of Surgical Scars with Fractional Carbon Dioxide ... This study demonstrates that CO 2 FL achieves more significant long-term results in surgical scars, including improved scar appearance, safety, and patient ...

5. apm.amegroups.org apm.amegroups.org/article/view/89904/html

A systematic review and meta-analysis on the effects of the ... Ultra-pulse CO2 fractional laser has the characteristics of less trauma, fast healing, less complications, less adverse reactions, and good ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3580980/

Fractional Carbon Dioxide Laser Resurfacing - PMC Currently available ablative fractional CO2 lasers provide excellent results and diminish down time with fewer complications than previous generation CO2 lasers ...

7. ijord.com ijord.com/index.php/ijord/article/view/676

Complications of fractional ablative carbon dioxide laser in ... The most common early side effects reported were erythema (95.38%) and burning sensation (92.30%) after the procedure. Post procedural dryness and edema was ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03644849

Evaluating the Safety and Efficacy of Fractionated Carbon ... This study will evaluate the efficacy and safety of laser therapy on postoperative lower extremity wound healing over 12 weeks.

9. aetna.com aetna.com/cpb/medical/data/400_499/0427.html

Carbon Dioxide Laser - Medical Clinical Policy Bulletins The authors concluded that reviewed evidence indicated this therapy offers a safe, effective treatment alternative for HHD with minimal risk of side-effects.