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

Trial Summary

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 data supports the effectiveness of the treatment Fractionated Laser Resurfacing for Actinic Keratosis and Skin Cancer Prevention?

Fractionated laser resurfacing has been shown to effectively treat facial actinic keratosis (pre-cancerous skin lesions) and improve skin texture and wrinkles with minimal side effects. It works by creating tiny zones of skin damage that stimulate new collagen formation, leading to skin rejuvenation and potentially reducing the risk of skin cancer. ^{1 2 3 4 5}

Is Fractionated Laser Resurfacing safe for humans?

Fractionated Laser Resurfacing, including Fraxel and CO2 laser treatments, is generally safe for humans. Studies report no severe side effects, with common temporary effects being redness and swelling. Long-term evaluations show no serious complications, indicating stable and safe results over time. ^{3 6 7 8 9}

How is Fractionated Laser Resurfacing different from other treatments for actinic keratosis?

Fractionated Laser Resurfacing is unique because it uses a laser to create tiny zones of heat injury in the skin, which are surrounded by untreated areas, allowing for faster healing and fewer side effects compared to traditional laser treatments. This method not only treats actinic keratosis but also helps rejuvenate the skin and improve scars, making it a versatile option. ^{1 2 5 7 10}

What is the purpose of this trial?

This study is following up on previous studies that have demonstrated that geriatric subjects respond different to ultraviolet B (UVB) light than young subjects. The treatment of geriatric skin with dermal rejuvenation therapies (dermabrasion, fractionated laser resurfacing) restores the appropriate UVB response. Ongoing studies have tested the ability of fractionated laser resurfacing (FLR) to assess how long this wounding effect lasts-and have found that this appears to be a durable response which lasts for at least two years. The findings that FLR protects geriatric skin at two years is the impetus for this study. This study is an interventional study to assess if FLR treatment of one forearm of geriatric subjects with multiple actinic keratosis will result in the short-term removal of actinic keratosis, and the long-term decrease in levels of future actinic keratosis and other non-melanoma skin cancers in comparison to the untreated arm. Study length and visit: The first part of the study is completed in 1 day then there are follow up visits at 90 days and every 6 months for 5 years.

Research Team

Jeffrey B Travers, MD, PhD

Principal Investigator

Wright State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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

Single Ablative Fractional Resurfacing Laser Treatment For Forearm Actinic Keratoses: 6-Month Follow-Up Data From An Intrapatient Comparison Between Treated and Untreated Sites. [2021]

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

Fractional CO(2) laser resurfacing. [2017]

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

Safe and effective one-session fractional skin resurfacing using a carbon dioxide laser device in super-pulse mode: a clinical and histologic study. [2022]

5. 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]

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

Non-sequential fractional ultrapulsed CO2 resurfacing of photoaged facial skin: preliminary clinical report. [2018]

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

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

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

Efficacy of light-emitting diode photomodulation in reducing erythema after fractional carbon dioxide laser resurfacing: a pilot study. [2013]

9. England pubmed.ncbi.nlm.nih.gov

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

10. 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]