80 Participants Needed

Laser Resurfacing for Precancerous Skin Lesions

MC
RS
Overseen ByRegulatory Specialist
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wright State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Fractionated Laser Resurfacing can protect the forearm and wrist skin from precancerous spots known as actinic keratosis (AKs) and help prevent skin cancer. Researchers are also investigating whether skin photos can predict where these spots might develop. The trial involves treating each forearm separately with the laser. Ideal participants are individuals aged 60 or older with 5 to 10 AKs on each forearm, fair skin, and no large tattoos or recent skin treatments on their forearms. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new preventive measures for skin cancer.

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 prior data suggests that the Fractionated Laser Resurfacing procedure is safe for treating precancerous skin lesions?

Research shows that Fractionated Laser Resurfacing (FLR) improves skin issues such as sun damage, scars, and wrinkles. Studies have found that it treats only part of the skin’s surface, aiding healing and shortening recovery time.

Patients generally tolerate FLR well. Common side effects include redness, swelling, and a sensation similar to a sunburn immediately after treatment. These effects typically disappear within a few days. Reports of serious side effects are rare. However, individual reactions can vary.

FLR has been used in dermatology for various skin concerns, supporting its safety. Consulting a healthcare professional for personal advice is always recommended.12345

Why are researchers excited about this trial?

Fractionated Laser Resurfacing is unique because it offers a non-invasive way to treat precancerous skin lesions by using laser technology to precisely target affected areas. Unlike traditional treatments like topical creams or surgical excision, this method reduces damage to surrounding healthy skin and may minimize recovery time. Researchers are excited because it could provide a more efficient and less painful alternative with potentially fewer side effects.

What evidence suggests that Fractionated Laser Resurfacing might be an effective treatment for actinic keratosis?

Research has shown that Fractionated Laser Resurfacing (FLR) effectively removes precancerous skin spots, such as actinic keratosis (AKs), potentially preventing skin cancer. Studies have found that this laser treatment clears sun-damaged skin, making it appear smoother and healthier. FLR targets and removes damaged skin cells, reducing the risk of developing skin cancers like squamous cell carcinoma and basal cell carcinoma. Additionally, this treatment improves skin texture and reduces signs of aging, such as wrinkles and sun spots. These benefits suggest that FLR could be a promising option for individuals with precancerous skin conditions. In this trial, participants will receive FLR treatment on either their right or left forearm to assess its effectiveness.24678

Who Is on the Research Team?

JT

Jeffrey Travers, MD, PhD

Principal Investigator

Wright State University

Are You a Good Fit for This Trial?

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)
See 2 more

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.
See 7 more

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 (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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Fractionated Laser Resurfacing - Right ArmExperimental Treatment1 Intervention
Group II: Fractionated Laser Resurfacing - Left ArmExperimental Treatment1 Intervention

Fractionated Laser Resurfacing is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Fractional Laser Resurfacing for:
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Approved in European Union as Fractional Laser Resurfacing for:
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Approved in Canada as Fractional Laser Resurfacing for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials
47
Recruited
55,300+

Published Research Related to This Trial

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

Citations

Total, Active and Deep FX | Cosmetic ServicesDeepFX is CO2 laser skin resurfacing for deeper wrinkles and scars that have a dermal component. This treatment also uses a fractional pattern to aid in the ...
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