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

12 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Fractionated Laser Resurfacing for skin rejuvenation?

Research shows that fractional laser resurfacing, including Fraxel and fractional CO2 lasers, is effective for reducing wrinkles and improving skin texture with less downtime compared to traditional methods. Studies report visible improvements in skin appearance and high patient satisfaction, making it a promising option for skin rejuvenation. ^{1 2 3 4 5}

How is Fractionated Laser Resurfacing different from other skin rejuvenation treatments?

Fractionated Laser Resurfacing is unique because it combines the benefits of traditional CO2 laser resurfacing with fractional photothermolysis, allowing for effective treatment of deeper skin issues like wrinkles and scars with shorter recovery time and fewer side effects. It uses a specialized lens to create high-intensity microtreatment zones, which are less painful and require no tracking dye, making it more comfortable and efficient than older laser technologies. ^{1 6 7 8 9}

What is the purpose of this trial?

It has shown that laser wounding of geriatric skin protects it against skin cancer. The purpose of this study is to determine the origin of cells called fibroblasts which are present after treatment with Fractionated Laser Resurfacing (FLR). These cells restore a youth-like ultraviolet B (UVB) response, but where they come from is currently unknown. The study recruits subjects who are scheduled to undergo abdominoplasties to investigate the origin of those cells stimulated by laser treatment.

Research Team

Jeffrey Travers, MD, PhD

Principal Investigator

Wright State University

Eligibility Criteria

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

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

My diabetes is not well-controlled.

Pregnant or nursing

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

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

Early improvement in rhytides and skin laxity following treatment with a combination fractional laser emitting two wavelengths sequentially. [2016]

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

Long-term efficacy of a fractional resurfacing device. [2010]

3. France pubmed.ncbi.nlm.nih.gov

[Fractional photo-thermolysis by laser Fraxel as an adjuvant for facial surgical rejuvenation]. [2007]

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

Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. [2022]

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

Fractional carbon dioxide laser resurfacing of rhytides and photoaged skin--a prospective clinical study on patient expectation and satisfaction. [2015]

6. United States 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. [2022]

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

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

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

Fractional CO(2) laser resurfacing. [2017]

9. 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]