The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population

Wright State University

Status: Enrolling

Conditions: Aging; Non-Melanoma Skin Cancer; Actinic Keratoses

Treatments: Device: Fractionated Laser Resurfacing

Study type: Interventional

Funder types: Other

Identifiers

NCT06428721

2023-346

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult Males and Females aged 60 and older
• Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
• Skin type fair (Fitzpatrick I-II)
• Females must be post-menopausal and not be on systemic hormone replacement therapy
• Able to comprehend procedures and risks

Exclusion criteria

• More than 10 AKs on an extremity
• AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
• AKs that are very thick (>3 mm)
• Medical history of diabetes
• History of poor wound healing or scarring
• Large tattoos that can interfere with study
• Other serious health issues and other skin diseases that could interfere with the study
• Recent (within 1 year) field therapies such as efudex cream or PDT to forearms/wrists.
• Planning to leave region in next 5 years
• Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Fractionated Laser Resurfacing - Right Arm

Experimental group

Description:

Right forearm treatment of fractionated laser resurfacing.

Treatment:

Device: Fractionated Laser Resurfacing

Fractionated Laser Resurfacing - Left Arm

Experimental group

Description:

Left forearm treatment of fractionated laser resurfacing.

Treatment:

Device: Fractionated Laser Resurfacing