Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2018
CompletedFirst Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 25, 2025
March 1, 2025
10.9 years
April 4, 2019
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Factionated Laser Resurfacing - Right Arm
EXPERIMENTALRight forearm treatment of fractionated laser resurfacing.
Factionated Laser Resurfacing - Left Arm
EXPERIMENTALLeft forearm treatment of fractionated laser resurfacing.
Interventions
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dayton VA Medical Center
Dayton, Ohio, 45428, United States
Related Publications (2)
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.
PMID: 34428179DERIVEDChen 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: 31736123DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey B Travers, MD, PhD
Wright State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 8, 2019
Study Start
January 10, 2018
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
March 25, 2025
Record last verified: 2025-03