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

Study Overview
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Brief Summary
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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.

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

Conditions
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Actinic Keratoses, Aging, Non-Melanoma Skin Cancer

Intervention / Treatment
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* Device: Fractionated Laser Resurfacing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Factionated Laser Resurfacing - Right Arm<br>Right forearm treatment of fractionated laser resurfacing. | Device: Fractionated Laser Resurfacing<br>* A rejuvenating laser that makes tiny holes in the very superficial part of the skin.<br>|
| Experimental: Factionated Laser Resurfacing - Left Arm<br>Left forearm treatment of fractionated laser resurfacing. | Device: Fractionated Laser Resurfacing<br>* A rejuvenating laser that makes tiny holes in the very superficial part of the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Actinic Keratosis due to FLR treatment. | Investigator will assess the number of actinic keratosis on both forearms. | up to 5 years | 
| Change From Baseline in the Number Non-Melanoma Skin Cancers due to FLR treatment. | Investigator will assess the number of actinic keratosis on both forearms. | up to 5 years |