Laser Resurfacing for Precancerous Skin Lesions

Overseen By Regulatory Specialist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wright State University

Must not be taking: Efudex, PDT, Xylocaine

Disqualifiers: Diabetes, Poor wound healing, 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: Up to 5 years

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on systemic hormone replacement therapy, you cannot participate in the trial.

What data supports the effectiveness of the treatment Fractionated Laser Resurfacing for precancerous skin lesions?

Research shows that fractional laser resurfacing, including Fraxel and fractionated CO2 lasers, is effective for treating various skin conditions like scars and photoaging (skin damage from the sun). These treatments create tiny, controlled injuries in the skin, which helps stimulate healing and improve skin appearance, suggesting potential benefits for precancerous lesions as well. ^{1 2 3 4 5}

Is laser resurfacing safe for treating skin conditions?

Research shows that fractional CO2 laser resurfacing is generally safe for treating skin conditions, with no long-term or serious complications observed in a large study. However, some side effects like scarring and redness can occur, similar to traditional laser treatments. ^{2 6 7 8 9}

How is Fractionated Laser Resurfacing different from other treatments for precancerous skin lesions?

Fractionated Laser Resurfacing is unique because it uses a laser to create tiny zones of skin damage surrounded by healthy tissue, which helps the skin heal faster and stimulates new collagen growth. This method offers a better balance between safety and effectiveness compared to traditional laser treatments, making it a novel option for skin resurfacing. ^{1 5 10 11 12}

What is the purpose of this trial?

The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.

Research Team

Jeffrey Travers, MD, PhD

Principal Investigator

Wright State University

Eligibility Criteria

This trial is for older adults with active precancerous skin lesions known as actinic keratosis. Participants should have a history of these lesions and be at risk for developing skin cancer. Specific eligibility criteria are not provided, but typically include being in good health and meeting certain medical parameters.

Inclusion Criteria

I understand the procedures and risks involved.

I am 60 years old or older.

Skin type fair (Fitzpatrick I-II)

Exclusion Criteria

I have a history of diabetes.

I've used skin treatments like efudex or PDT on my arms within the last year.

My skin growth is thicker than 3 mm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fractionated Laser Resurfacing (FLR) on one forearm/wrist to prevent actinic keratosis and skin cancer

Up to 5 years

Regular visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fractionated Laser Resurfacing

Trial Overview The study is examining whether Fractionated Laser Resurfacing (FLR) can prevent the formation of actinic keratosis and potentially stop skin cancer from developing on one forearm/wrist. It also explores if photographs can predict lesion development.

Participant Groups

Group I: Fractionated Laser Resurfacing - Right Arm Experimental Treatment 1 Intervention

Right forearm treatment of fractionated laser resurfacing.

Group II: Fractionated Laser Resurfacing - Left Arm Experimental Treatment 1 Intervention

Left forearm treatment of 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

In a study involving 30 female Asian patients, higher fluences in Fraxel laser treatment led to greater patient satisfaction, indicating that using more energy can enhance treatment outcomes.

However, higher density settings resulted in more significant side effects like pain, swelling, and hyperpigmentation, suggesting that while fluence improves satisfaction, it is important to balance it with safety to minimize adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective direct comparison study of fractional resurfacing using different fluences and densities for skin rejuvenation in Asians. Kono, T., Chan, HH., Groff, WF., et al.[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]

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]

Fractional photothermolysis using a 1550-nm erbium fiber laser is a safe and effective treatment for various skin issues, including photodamage and atrophic acne scars, requiring multiple sessions (3 to 6) for optimal results.

While Fraxel treatments can achieve significant improvement for atrophic scars comparable to traditional ablative laser resurfacing, they may not be as effective for treating perioral laxity and wrinkles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fraxel laser indications and long-term follow-up. Tanzi, EL., Wanitphakdeedecha, R., Alster, TS.[2018]

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]

In a study of 312 patients with photodamaged facial skin, a single treatment with fractional ultrapulsed CO2 laser showed significant improvements in skin condition at 3, 6, and 24 months post-treatment, indicating its efficacy.

The long-term results demonstrated that improvements in skin appearance were stable for at least 2 years after the procedure, with no serious complications reported, highlighting the safety of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Random fractional ultrapulsed CO2 resurfacing of photodamaged facial skin: long-term evaluation. Tretti Clementoni, M., Galimberti, M., Tourlaki, A., et al.[2022]

Despite advancements in technology, including the use of fractionated CO2 laser resurfacing, patients may still experience adverse effects similar to those from traditional CO2 laser treatments, such as scarring and hypopigmentation.

A case study of a 55-year-old female revealed these side effects occurred just 9 days after undergoing fractionated ablative CO2 laser resurfacing, highlighting the need for continued evaluation of safety in new laser technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scarring and persistent erythema after fractionated ablative CO2 laser resurfacing. Ross, RB., Spencer, J.[2022]

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]

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]

Fractional ablative laser resurfacing, particularly using the fractional carbon dioxide (CO2) laser, provides a better balance of safety and efficacy compared to traditional ablative methods, making it a promising option for skin treatments.

A multi-center clinical study demonstrated the effectiveness of fractional CO2 laser in treating various skin conditions such as wrinkles, photoaging, scars, and stretch marks, highlighting its versatility in dermatological applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-center clinical study and review of fractional ablative CO2 laser resurfacing for the treatment of rhytides, photoaging, scars and striae. Alexiades-Armenakas, M., Sarnoff, D., Gotkin, R., et al.[2014]

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]

The combination of CO2 laser and radiofrequency waves in fractional laser resurfacing offers both immediate skin resurfacing and deeper skin remodeling, making it a promising technique for treating conditions like photoaging and scars.

A pilot study involving 15 patients with acne scars demonstrated the effectiveness of this new machine, supported by preclinical histological evidence, indicating potential for improved therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined use of fractional CO2 laser and radiofrequency waves to treat acne scars: a pilot study on 15 patients. Tenna, S., Cogliandro, A., Piombino, L., et al.[2015]

References

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

Prospective direct comparison study of fractional resurfacing using different fluences and densities for skin rejuvenation in Asians. [2022]

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

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

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Fraxel laser indications and long-term follow-up. [2018]

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

Fractional CO(2) laser resurfacing. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Random fractional ultrapulsed CO2 resurfacing of photodamaged facial skin: long-term evaluation. [2022]

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

Scarring and persistent erythema after fractionated ablative CO2 laser resurfacing. [2022]

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

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

9. France pubmed.ncbi.nlm.nih.gov

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

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

Multi-center clinical study and review of fractional ablative CO2 laser resurfacing for the treatment of rhytides, photoaging, scars and striae. [2014]

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

Combined use of fractional CO2 laser and radiofrequency waves to treat acne scars: a pilot study on 15 patients. [2015]