Clinical trial NCT03906253: Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Official title: Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Actinic Keratoses
Aging
Non-Melanoma Skin Cancer
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Number of Actinic Keratosis due to FLR treatment.
timeFrame: up to 5 years
measure: Change From Baseline in the Number Non-Melanoma Skin Cancers due to FLR treatment.
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Dayton VA Medical Center
state: Ohio
Study officials:
affiliation: Wright State University
name: Jeffrey B Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spandau DF, Chen R, Wargo JJ, Rohan CA, Southern D, Zhang A, Loesch M, Weyerbacher J, Tholpady SS, Lewis DA, Kuhar M, Tsai KY, Castellanos AJ, Kemp MG, Markey M, Cates E, Williams AR, Knisely C, Bashir S, Gabbard R, Hoopes R, Travers JB. Randomized controlled trial of fractionated laser resurfacing on aged skin as prophylaxis against actinic neoplasia. J Clin Invest. 2021 Oct 1;131(19):e150972. doi: 10.1172/JCI150972.
citation: Chen R, Wargo JJ, Williams A, Cates E, Spandau DF, Knisely C, Travers JB. Single Ablative Fractional Resurfacing Laser Treatment For Forearm Actinic Keratoses: 6-Month Follow-Up Data From An Intrapatient Comparison Between Treated and Untreated Sites. Lasers Surg Med. 2020 Jan;52(1):84-87. doi: 10.1002/lsm.23175. Epub 2019 Nov 17.