Fractionated Laser Resurfacing for Actinic Keratosis and Skin Cancer Prevention

Recruiting in Palo Alto (17 mi)

Overseen by Jeffrey B Travers, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jeffrey B. Travers, MD, PhD

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

Disqualifiers: Uncontrolled diabetes, Pregnancy, Keloids, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dayton VA Medical Center Dayton, OH

Who Is Running the Clinical Trial?

Jeffrey B. Travers, MD, PhD Lead Sponsor

Wright State University Lead Sponsor

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] Actinic keratoses (AK) are common pre-cancerous lesions, which are associated with ultraviolet light exposure and aging. Wounding therapies such as fractionated laser resurfacing (FLR) have been previously demonstrated to effectively treat facial AK. However, the effectiveness of FLR on other sites commonly afflicted with AK has not been studied in detail. Previously, our group has reported that treatment of aged skin with wounding therapies including dermabrasion and ablative fractionated resurfacing results in the removal of senescent fibroblasts and normalizing the pro-carcinogenic acute ultraviolet B radiation responses associated with aged skin. The current studies were designed to test the effectiveness of FLR of the forearm skin of subjects aged 60 and older to remove AKs.

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

Fractional CO(2) laser resurfacing. [2017] Fractionated CO(2) lasers are a new treatment modality for skin resurfacing. These lasers have been shown efficacious in treating facial photoaging changes and scars. These lasers have an improved safety and recovery profile compared with traditional CO(2) laser resurfacing. Precise treatment parameters vary between patients, the pathology treated, and the details of the particular laser.

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

[Fractional photo-thermolysis by laser Fraxel as an adjuvant for facial surgical rejuvenation]. [2007] The fractional resurfacing (Fraxel laser) is a new procedure for facial and extrafacial rejuvenation. His claim is obtain a great efficacy on wrinkles, close to those of the CO(2) and erbium lasers, but without their risks and long lasting down time. We use a scanner, able to create multiple (around 2000 to 3000/cm(2)) 70-150 microns diameter microthermal zones surrounded by islands of viable tissue. The reepithelialization is complete in a day, but there is a collagen denaturization in the dermis, between 300-750 microns like after a traditional resurfacing. At each session, around 25% of the dermis are treated. 4 treatments are performed with a 1 to 2 weeks interval. We report our comprehensive results since we began in December 2004. At the time of the abstract, 600 sessions were performed (150 Patients). A visible reduction of wrinkles is observed anytime, with improvement of the texture of the skin, and in the same time, a dramatic improvement of the pigmented lesions. About tolerance, no severe side effects or dyschromia were noticed. We observed two case of limited erosion, (one of the first patients) due to a practical problem (bulk heating). The average erythema duration is 2 days. On the face, a 2-4 days edema occurs in many of the patients. Fraxel laser treatment is not designed as a substitute for surgical skin tightening such as facelift. Therefore, the fractional resurfacing is safe and effective for a visible reduction of wrinkles and appears as a very interesting treatment in association with face lift to rejuvenate the face.

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] Carbon dioxide (CO(2)) laser ablative fractional resurfacing produces skin damage, with removal of the epidermis and variable portions of the dermis as well as associated residual heating, resulting in new collagen formation and skin tightening. The nonresurfaced epidermis helps tissue to heal rapidly, with short-term postoperative erythema. The results for 40 patients (8 men and 32 women) after a single session of a fractional CO(2) resurfacing mode were studied. The treatments included resurfacing of the full face, periocular upper lip, and residual acne scars. The patients had skin prototypes 2 to 4 and wrinkle degrees 1 to 3. The histologic effects, efficacy, and treatment safety in various clinical conditions and for different phototypes are discussed. The CO(2) laser for fractional treatment is used in super-pulse mode. The beam is split by a lens into several microbeams, and super-pulse repetition is limited by the pulse width. The laser needs a power adaptation to meet the set fluence per microbeam. Laser pulsing can operate repeatedly on the same spot or be moved randomly over the skin, using several passes to achieve a desired residual thermal effect. Low, medium, and high settings are preprogrammed in the device, and they indicate the strength of resurfacing. A single treatment was given with the patient under topical anesthesia. However, the anesthesia was injected on areas of scar tissue. Medium settings (2 Hz, 30 W, 60 mJ) were used, and two passes were made for dark skins and degree 1 wrinkles. High settings (2 Hz, 60 W, 120 mJ) were used, and three passes were made for degree 3 wrinkles and scar tissue. Postoperatively, resurfaced areas were treated with an ointment of gentamycin, Retinol Palmitate, and DL-methionine (Novartis; Farmaceutics, S.A., Barcelona, Spain). Once epithelialization was achieved, antipigment and sun protection agents were recommended. Evaluations were performed 15 days and 2 months after treatment by both patients and clinicians. Treatment improved wrinkle aspect and scar condition, and no patient reported adverse effects or complications, irrespective of skin type, except for plaques of erythema in areas that received extra laser passes, which were not seen at the 2-month assessment. The results evaluated by clinicians were very much in correlation with those of patients. Immediately after treatment, vaporization was produced by stacked pulses, with clear ablation and collateral heat coagulation. An increased number of random pulses removed more epidermis, and with denser pulses per area, a thermal deposit was noted histologically. At 2 months, a thicker, multicelluar epidermis and an evident increase in collagen were observed. Fractional CO(2) laser permits a variety of resurfacing settings that obtain safe, effective skin rejuvenation and correct scar tissue in a single treatment.

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] Fractional resurfacing is a new concept of cutaneous remodeling whereby laser-induced zones of microthermal injury are surrounded by normal untreated tissue. The aim of this study is to compare the efficacy and complications of Fraxel laser treatment when using different fluences and density settings.

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

Non-sequential fractional ultrapulsed CO2 resurfacing of photoaged facial skin: preliminary clinical report. [2018] This study evaluates results, adverse side effects and downtime of the protocol 'ActiveFX' for photodamaged facial skin. A non-sequential fractional ultrapulsed CO2 laser with specific settings is used in addition to a new computer pattern generator (CPG). From September 2006 to March 2007, 55 patients underwent this new 'soft' single-session, single-pass and full-face ablative fractional treatment. The patients were evaluated at baseline and 1 and 3 months after the treatment using a five-point scale. Seven aspects of photodamaged skin were recorded: global score, fine lines, mottled pigmentation, sallow complexion, tactile roughness, coarse wrinkles and telangiectasias. The results were compared with a non-parametric statistical test, the Wilcoxon's exact test. Eight patients received a double-pass treatment on the crow's feet regions and the improvement of the coarse wrinkles was analyzed with a quartile grading scale. Significant differences (p

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

Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. [2022] Ablative fractional resurfacing (AFR) is a new modality for photorejuvenation and acne scars which combines carbon dioxide (CO₂) laser ablation with fractional photothermolysis. The objective is to evaluate the efficacy and side effects of a new fractional CO₂ ablative device (Fraxel Re:pair) for skin rejuvenation and acne scars in Asians.

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] The most common side effects of fractional carbon dioxide (CO2 ) laser resurfacing are erythema and edema of the treated skin. Light-emitting diode (LED) devices have been shown to stimulate fibroblast activity and hasten wound healing. The current study was designed to evaluate the efficacy of such LED devices in treating post-laser therapy erythema.

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

Random fractional ultrapulsed CO2 resurfacing of photodamaged facial skin: long-term evaluation. [2022] Although numerous papers have recently been published on ablative fractional resurfacing, there is a lack of information in literature on very long-term results. The aim of this retrospective study is to evaluate the efficacy, adverse side effects, and long-term results of a random fractional ultrapulsed CO2 laser on a large population with photodamaged facial skin. Three hundred twelve patients with facial photodamaged skin were enrolled and underwent a single full-face treatment. Six aspects of photodamaged skin were recorded using a 5 point scale at 3, 6, and 24 months after the treatment. The results were compared with a non-parametric statistical test, the Wilcoxon's exact test. Three hundred one patients completed the study. All analyzed features showed a significant statistical improvement 3 months after the procedure. Three months later all features, except for pigmentations, once again showed a significant statistical improvement. Results after 24 months were similar to those assessed 18 months before. No long-term or other serious complications were observed. From the significant number of patients analyzed, long-term results demonstrate not only how fractional ultrapulsed CO2 resurfacing can achieve good results on photodamaged facial skin but also how these results can be considered stable 2 years after the procedure.

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] Fractionated carbon dioxide CO(2) laser resurfacing unites the idea of fractional photothermolysis with an ablative 10,600-nm wavelength. This technology permits effective treatment of deeper rhytides, photodamaged skin, and scars, with shorter recovery and a decreased side effect profile as compared to traditional CO(2) laser resurfacing.