Fractionated Laser Resurfacing for Actinic Keratosis and Skin Cancer Prevention

Overseen By Regulatory Specialist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jeffrey B. Travers, MD, PhD

Must not be taking: Anti-inflammatories, Steroids, Photosensitizers

Disqualifiers: Uncontrolled diabetes, Pregnancy, Keloids, 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: 91

Duration: 1 day

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a laser treatment called Fractionated Laser Resurfacing (FLR) can prevent skin issues in older skin, such as actinic keratosis (rough, scaly patches from sun exposure) and other non-melanoma skin cancers. Researchers test the treatment on one forearm to assess both short-term and long-term effects. Individuals diagnosed with actinic keratosis within the last six months and who have fair skin might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new preventative treatments for skin conditions.

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

Yes, you will need to stop using any topical or oral anti-inflammatory medications or steroids, as well as any photosensitizing medications.

What prior data suggests that fractionated laser resurfacing is safe for geriatric skin?

Research has shown that fractionated laser resurfacing (FLR) is generally well-tolerated. In past studies, patients experienced improvements in skin texture and a reduction in sun damage. This treatment uses tiny laser beams to target and refresh the skin.

Some individuals might experience minor side effects like redness or swelling, but these typically resolve quickly. FLR has also shown promise in treating early signs of skin issues such as actinic keratosis. Evidence suggests it is a safe option for refreshing the skin and may help reduce the risk of future skin cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fractionated Laser Resurfacing is unique because it offers a novel approach to treating actinic keratosis and preventing skin cancer by using laser technology. Unlike traditional treatments like cryotherapy, topical medications, or chemical peels, which can be invasive, take time to heal, or might target the surface of the skin, this laser treatment works by precisely targeting and vaporizing damaged skin cells in a fractionated manner. This means it only treats small areas at a time, allowing for faster recovery and minimal downtime. Researchers are excited about this because it not only treats existing lesions effectively but also promotes healthier skin regeneration, potentially reducing the risk of future skin cancers.

What evidence suggests that fractionated laser resurfacing might be an effective treatment for actinic keratosis?

Research has shown that fractionated laser resurfacing (FLR) effectively treats sun-damaged skin and early-stage conditions like actinic keratosis. Studies have found that FLR improves skin texture and reduces skin cancer risk by removing damaged skin cells. Evidence suggests that this treatment provides protection lasting at least two years. In this trial, participants will receive FLR treatment on either the left or right forearm. The laser creates tiny wounds in the skin, prompting the body to heal and renew it. This process not only clears existing damage but may also help prevent future skin problems. ^{1 2 4 5 6}

Who Is on the Research Team?

Jeffrey B Travers, MD, PhD

Principal Investigator

Wright State University

Are You a Good Fit for This Trial?

This trial is for people aged 60 or older with a recent diagnosis of Actinic Keratosis, fair skin (Fitzpatrick Type I or II), and both forearms intact. They must understand the study's procedures and risks/benefits, and be able to consent. Excluded are those allergic to lidocaine, on photosensitizing meds, pregnant/nursing women, users of anti-inflammatory drugs/steroids, uncontrolled diabetics, individuals prone to abnormal scarring or worsening of conditions in sunlight.

Inclusion Criteria

You have very fair skin.

You have both your right and left forearms.

I was diagnosed with Actinic Keratosis less than 6 months ago.

Exclusion Criteria

Pregnant or nursing

I understand the procedures and can weigh the risks versus benefits.

I am using anti-inflammatory medication or steroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractionated laser resurfacing treatment on one forearm

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at 90 days and every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fractionated Laser Resurfacing

Trial Overview The study tests if Fractionated Laser Resurfacing (FLR) on one forearm can remove Actinic Keratosis short-term and reduce future non-melanoma skin cancers long-term compared to an untreated arm. The initial treatment takes one day with follow-ups at 90 days then every six months for five years.

How Is the Trial Designed?

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

Right forearm treatment of fractionated laser resurfacing.

Group II: Factionated 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?

Jeffrey B. Travers, MD, PhD

Lead Sponsor

Trials

5

Recruited

160+

Wright State University

Lead Sponsor

Trials

47

Recruited

55,300+

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]

The 'ActiveFX' treatment using a non-sequential fractional ultrapulsed CO2 laser showed significant improvement in various aspects of photodamaged skin, including fine lines and coarse wrinkles, evaluated in 55 patients over a 3-month period.

This treatment had minimal side effects and low downtime, making it a promising option for patients seeking to improve their facial skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-sequential fractional ultrapulsed CO2 resurfacing of photoaged facial skin: preliminary clinical report. Clementoni, MT., Gilardino, P., Muti, GF., et al.[2018]

In a study involving 10 Korean participants, the use of a 635-nm wavelength LED array after fractional CO2 laser resurfacing significantly reduced post-treatment erythema compared to the untreated control side.

Improvements in erythema were first observed on day 4, indicating that LED photomodulation can effectively hasten the healing process and reduce redness following laser therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of light-emitting diode photomodulation in reducing erythema after fractional carbon dioxide laser resurfacing: a pilot study. Oh, IY., Kim, BJ., Kim, MN., et al.[2013]

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]

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 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]

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 single treatment of fractionated laser resurfacing (FLR) on the forearm skin of 30 subjects aged 60 and older resulted in a significant 62% reduction in actinic keratoses (AKs) after 6 months, indicating its efficacy as a treatment.

The FLR treatment was well-tolerated by participants, with no major complications reported, suggesting it is a safe option for managing pre-cancerous lesions associated with aging and UV exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Ablative Fractional Resurfacing Laser Treatment For Forearm Actinic Keratoses: 6-Month Follow-Up Data From An Intrapatient Comparison Between Treated and Untreated Sites. Chen, R., Wargo, JJ., Williams, A., et al.[2021]

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]

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. kpcosmeticservices.com kpcosmeticservices.com/procedure/nonsurgical/laser-nonsurgical-services/total-active-and-deep-fx/

Total, Active and Deep FX | Cosmetic Services ActiveFX is CO2 laser skin resurfacing for the active person. It is a fractional laser treatment, meaning only a fraction of the skin's surface is treated ...

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. mdcsnyc.com mdcsnyc.com/post/fractionated-co2-laser-resurfacing-rejuvenate-skin-and-reduce-cancer-risk-with-dr-snehal-amin

Fractionated CO2 Laser Resurfacing: Rejuvenate Skin and ... Fractionated CO2 laser resurfacing improves skin texture and treats precancerous lesions like actinic keratosis. Dr. Snehal Amin offers this ...

5. perfectskinderm.com perfectskinderm.com/fractionated-co2-laser-resurfacing/

Fractionated CO2 Laser Resurfacing CO2 is the benchmark for laser skin rejuvenation. At Perfect Skin, we use the Lumenis Acupulse system, delivering both the DeepFX and Active FX resurfacing ...

6. 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.