Randomized controlled trial of fractionated laser resurfacing on aged skin as prophylaxis against actinic neoplasia.
Dan F Spandau, Roy Chen, Jeffrey J Wargo...
https://pubmed.ncbi.nlm.nih.gov/34428179Actively Recruiting
Phase Not Applicable
Age: 60Years +
All Genders
ID03906253
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Led by Wright State University · Updated on 2025-03-25
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how fractionated laser resurfacing (FLR), a skin treatment that creates tiny holes in the skin's surface, affects older adults with actinic keratosis, a skin condition linked to aging and sun damage. Previous studies showed that older skin responds differently to ultraviolet B (UVB) light compared to younger skin, but treatments like FLR may restore a healthier UVB response. This trial aims to see if FLR can reduce actinic keratosis and other non-melanoma skin cancers over time. In this randomized study, participants receive FLR treatment on one forearm while the other forearm remains untreated for comparison. The treatment involves using a device that rejuvenates the skin by making small controlled wounds. The initial treatment takes one day, followed by follow-up visits at 90 days and then every six months for a total of five years to monitor effects. During the study, participants will have their number of actinic keratosis spots and non-melanoma skin cancers measured regularly to track changes from baseline. The research team will observe both short-term removal of lesions and long-term protection effects. Participants’ skin health and any side effects will be monitored throughout the five-year follow-up period to evaluate the durability and safety of the FLR treatment.
CONDITIONS
Brief Title
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with Actinic Keratosis within the past 6 months
- At least 60 years of age or older
- Ability to understand procedures and risks versus benefits
- Able to provide informed consent
- Fair skin (Fitzpatrick Type I or II)
- Possess both right and left forearms
You will not qualify if you...
- Uncontrolled diabetes mellitus
- Unable to understand procedures or risks versus benefits
- Pregnant or nursing
- Large tattoos on forearms
- History of abnormal healing or scarring such as keloids
- Any disease that worsens with sun exposure
- Use of topical or oral anti-inflammatory medications or steroids
- Allergy to lidocaine
- Current use of photosensitizing medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single treatment session
Participants receive fractionated laser resurfacing treatment on either the right or left forearm as part of the study.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants are monitored for changes in actinic keratosis and non-melanoma skin cancers over time following treatment.
Periodic visits for follow-up assessments
Trial Site Locations
Total: 1 location
1
Dayton VA Medical Center
Dayton, Ohio, United States, 45428
Actively Recruiting
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Research Team
M
Manager, Clinical Research Operations
R
Regulatory Specialist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Single Ablative Fractional Resurfacing Laser Treatment For Forearm Actinic Keratoses: 6-Month Follow-Up Data From An Intrapatient Comparison Between Treated and Untreated Sites.
Roy Chen, Jeffrey J Wargo, Amy Williams...
https://pubmed.ncbi.nlm.nih.gov/31736123