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Recruiting NCT03906253

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

No phase Interventional Actinic Keratoses Aging Non-Melanoma Skin Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fractionated Laser Resurfacing.
Who it may be relevant to
Registry conditions: Actinic Keratoses, Aging, Non-Melanoma Skin Cancer. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Fractionated Laser Resurfacing
    A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Primary outcome measures

  • Change From Baseline in the Number of Actinic Keratosis due to FLR treatment. [Time frame: up to 5 years]
  • Change From Baseline in the Number Non-Melanoma Skin Cancers due to FLR treatment. [Time frame: up to 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Dayton VA Medical Center — Dayton

Publications

  • 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. do PMID 34428179
  • 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. PMID 31736123

Identifiers

NCT: NCT03906253 · 06438

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗