Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia

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

NCT03906253

06438

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Actinic Keratosis within the past 6 months
• At least 60 years of age, or older
• Ability to comprehend procedures and risks versus benefits
• Able to provide Informed Consent
• Fair Skin (Fitzpatrick Type I or II)
• Possess both Right and Left Forearms

Exclusion criteria

• Uncontrolled Diabetes Mellitus
• Not able to comprehend procedures or risks versus benefits
• Pregnant or nursing
• Large tattoos on forearms
• History of abnormal healing or scarring (i.e., keloids)
• Any disease that gets worse while in the sun
• Use of topical or oral anti-inflammatory medication or steroids
• Allergy to lidocaine
• Current use of photosensitizing medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Factionated Laser Resurfacing - Right Arm

Experimental group

Description:

Right forearm treatment of fractionated laser resurfacing.

Treatment:

Device: Fractionated Laser Resurfacing

Factionated Laser Resurfacing - Left Arm

Experimental group

Description:

Left forearm treatment of fractionated laser resurfacing.

Treatment:

Device: Fractionated Laser Resurfacing