Laser Resurfacing for Skin Rejuvenation

Overseen By Regulatory Specialist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wright State University

Disqualifiers: Uncontrolled diabetes, Pregnant, Keloidal scars, 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: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the origin of certain skin cells, called fibroblasts, after Fractionated Laser Resurfacing (FLR) treatment. These cells help the skin respond to UVB light as it did in youth and might protect against skin cancer. Participants will have two small areas of their skin treated with FLR before undergoing planned tummy tuck surgery. Individuals planning this surgery with sufficient skin to be removed are suitable candidates for the study. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially enhance skin health.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that Fractionated Laser Resurfacing is safe?

Research has shown that Fractionated Laser Resurfacing (FLR) is generally well-tolerated. Studies have found that this laser treatment effectively refreshes the skin by reducing sun damage, scars, and wrinkles. The technology treats the skin in small sections, leaving some areas untouched, which helps the skin heal faster and reduces side effects.

Most people experience temporary redness and swelling after the treatment, which usually subsides in a few days. Serious side effects are rare, but there is a small risk of scarring or infection. Overall, this treatment has fewer complications than older laser methods. For safety concerns, consulting a healthcare provider is recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fractionated laser resurfacing for skin rejuvenation because it offers a precise and controlled way to improve skin texture and appearance. Unlike traditional laser treatments that may remove the entire top layer of skin, this method targets only a fraction of the skin at a time, promoting faster healing and reducing downtime. Additionally, it stimulates collagen production more effectively, potentially leading to longer-lasting results compared to standard options like chemical peels or microdermabrasion.

What evidence suggests that Fractionated Laser Resurfacing is effective for skin rejuvenation?

Research has shown that Fractionated Laser Resurfacing (FLR) effectively treats sun-damaged and aging skin. Studies indicate that this treatment can improve skin texture, reduce wrinkles, and treat sunspots. The laser creates tiny wounds in the skin, prompting the body to produce new, healthy skin cells. This process can lead to a more youthful appearance and may help protect against further skin damage. Initial findings also suggest that it might help protect against skin cancer by altering how the skin responds to UVB light. Overall, FLR is a promising option for refreshing skin and enhancing its appearance. Participants in this trial will receive FLR treatment on designated areas of the abdomen to further evaluate its effectiveness. ^{1 3 5 6 7}

Who Is on the Research Team?

Jeffrey Travers, MD, PhD

Principal Investigator

Wright State University

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for abdominoplasty who may benefit from Fractionated Laser Resurfacing (FLR) to potentially protect against skin cancer. The study focuses on understanding how FLR treatment rejuvenates the skin by examining fibroblasts, cells that help repair damaged skin.

Inclusion Criteria

I understand the procedures and risks involved.

I am planning to have a tummy tuck surgery.

I need surgery to remove a skin area of at least 50 x 20cm.

Exclusion Criteria

Pregnant or nursing

My diabetes is not well-controlled.

Existing tattoos on the abdomen that are so extensive that they could interfere with the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fractionated Laser Resurfacing (FLR) is applied to specific areas of the abdomen 14 and 7 days prior to scheduled surgery

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for cell population changes and fibroblast origins after FLR treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fractionated Laser Resurfacing

Trial Overview The trial investigates the origin of fibroblasts after Fractionated Laser Resurfacing treatment in patients undergoing abdominoplasty. It aims to understand how these cells contribute to a youthful UVB response and possibly prevent skin cancer.

How Is the Trial Designed?

Group I: Fractionated Laser Resurfacing Experimental Treatment 1 Intervention

At 14 days prior to scheduled surgery a 5x5cm square on the left abdomen within the region of skin to be excised and treated with fractionated laser resurfacing. Then at 7 days prior to scheduled surgery a 5 cm diameter circle on the right abdomen within the region of skin to be excised, at least 10 cm away from the square, is treated with fractionated laser resurfacing.

Fractionated Laser Resurfacing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fractional Laser Resurfacing for:

• Wrinkles
• Scars
• Sun damage
• Melasma
• Actinic keratosis
• Non-melanoma skin cancers

Approved in European Union as Fractional Laser Resurfacing for:

• Wrinkles
• Scars
• Sun damage
• Melasma
• Actinic keratosis
• Non-melanoma skin cancers

Approved in Canada as Fractional Laser Resurfacing for:

• Wrinkles
• Scars
• Sun damage
• Melasma
• Actinic keratosis
• Non-melanoma skin cancers

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials

47

Recruited

55,300+

Published Research Related to This Trial

Ablative fractional CO₂ laser resurfacing using the Fraxel Re:pair device showed statistically significant improvements in skin texture, laxity, wrinkles, enlarged pores, and acne scars in a study of nine Asian patients, indicating its efficacy for skin rejuvenation.

Despite the overall satisfaction rate of 86% among patients, the treatment had a high post-inflammatory hyperpigmentation rate of 55.5% shortly after treatment, suggesting a need for caution and further evaluation of its safety compared to non-ablative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. Chan, NP., Ho, SG., Yeung, CK., et al.[2022]

In a study of 24 female patients undergoing three fractional CO2-laser treatments, patient satisfaction with skin appearance significantly improved after treatment, exceeding their initial high expectations.

Despite no direct correlation between measured wrinkle reduction and patient satisfaction, the treatment led to enhanced skin-related quality of life and self-esteem, making it a recommended option for those seeking to improve photoaged skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional carbon dioxide laser resurfacing of rhytides and photoaged skin--a prospective clinical study on patient expectation and satisfaction. Kohl, E., Meierhöfer, J., Koller, M., et al.[2015]

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]

The Fraxel laser procedure offers a safe and effective method for reducing wrinkles and improving skin texture, with results comparable to traditional CO2 and erbium lasers but with less downtime and fewer risks.

In a study involving 150 patients and 600 treatment sessions, no severe side effects were reported, and the average recovery time included only 2 days of erythema and 2-4 days of edema, making it a viable option for facial rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fractional photo-thermolysis by laser Fraxel as an adjuvant for facial surgical rejuvenation]. Buis, J., Mazer, JM.[2007]

Newer fractional laser technologies, which do not require tracking dye and create shallower microtreatment zones, are less painful and more effective for treating photoaged skin compared to older models.

In a study involving 16 Caucasian females, just 1 to 3 treatments with the new combination fractional laser device led to noticeable improvements in periocular wrinkles and skin laxity, demonstrating its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early improvement in rhytides and skin laxity following treatment with a combination fractional laser emitting two wavelengths sequentially. Foster, KW., Kouba, DJ., Fincher, EE., et al.[2016]

A single session of fractional CO(2) laser resurfacing in 40 patients led to significant improvements in wrinkles and acne scars, with no reported adverse effects except for temporary erythema in some areas.

The treatment was safe and effective across different skin types, resulting in increased collagen formation and a thicker epidermis observed two months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective one-session fractional skin resurfacing using a carbon dioxide laser device in super-pulse mode: a clinical and histologic study. Trelles, MA., Shohat, M., Urdiales, F.[2022]

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]

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]

Citations

1. medicine.umich.edu medicine.umich.edu/dept/cosmeticderm/procedures/laser-treatments/fractionated-laser-resurfacing-rejuvenation

Fractionated Laser Resurfacing and Rejuvenation We are pleased to offer our patients treatment with a type laser that will change the way sun damaged, scarred, and wrinkled skin is treated for years to come.

2. 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 ...

3. facebeautyscience.com facebeautyscience.com/active-fx-deep-fx-fractional-laser-mi/

Active FX™ and Deep FX™ Fractional CO2 Laser Revolutionize your skincare with Active FX and Deep FX Fractional CO2 Laser treatments. Say goodbye to sun damage and hello to clear, rejuvenated skin.

4. dermsanantonio.com dermsanantonio.com/services/active-fx-deep-fx-fractional-co2/

Active/Deep Fx Fractional Co2 Laser Resurfacing Laser resurfacing can dramatically improve many of the signs of aging including skin laxity, sun spots, and textural irregularities.

5. skinandvein.com skinandvein.com/dermatology-michigan/laser-treatments/skin-rejuvenation-tightening/fractional-laser-resurfacing/

Best CO2 Laser Resurfacing Michigan CO2 laser resurfacing is a rejuvenation treatment to minimize or eradicate photo-damaged skin and other conditions that cause the skin to appear older.

6. gendlerdermatology.com gendlerdermatology.com/activefx/

ActiveFX Treatments in New York | Laser Resurfacing with ... Active FX is a high-energy beam laser treatment applied in a fractionated pattern, like pixels in a photograph, leaving “bridges” of untouched skin.

7. drsparano.com drsparano.com/laser-skin-resurfacing

TotalFX™ Laser Skin Resurfacing New Jersey NJ This regenerated collagen helps prevent the tendency for facial skin to involute with a “crepe paper” pattern of wrinkling as it ages. Unlike most laser ...