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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2028-12-31

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.

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Detailed Description

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Conditions

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Actinic Keratoses Aging Non-Melanoma Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Factionated Laser Resurfacing - Right Arm

Right forearm treatment of fractionated laser resurfacing.

Group Type EXPERIMENTAL

Fractionated Laser Resurfacing

Intervention Type DEVICE

A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Factionated Laser Resurfacing - Left Arm

Left forearm treatment of fractionated laser resurfacing.

Group Type EXPERIMENTAL

Fractionated Laser Resurfacing

Intervention Type DEVICE

A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Interventions

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Fractionated Laser Resurfacing

A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Intervention Type DEVICE

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No