Actively Recruiting
The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
Led by Wright State University · Updated on 2024-07-24
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Fractionated Laser Resurfacing (FLR) to protect one forearm or wrist from precancerous actinic keratosis (AKs) and to prevent skin cancer in older adults with active AKs. This study also tests whether photographs of the skin can help predict where AKs and skin cancers may develop. The trial is focused on an at-risk geriatric population with fair skin and multiple AKs on their forearms or wrists. Participants receive FLR treatment on either the right or left forearm/wrist, with the procedure creating tiny holes in the very superficial skin layer. The study randomly assigns which forearm receives the treatment. This approach allows comparison between treated and untreated areas on the same person. The study builds on earlier research and monitors participants for up to five years. During the trial, participants will be regularly assessed for changes in the number of actinic keratosis lesions and non-melanoma skin cancers on their forearms. Researchers will also evaluate changes in skin dysplasia related to these conditions. Study visits include skin examinations and photographic documentation. The study tracks long-term outcomes over five years to understand FLR's preventive effects and monitors participant health throughout this period.
CONDITIONS
Brief Title
The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males and females aged 60 and older
- Have at least 5 actinic keratosis lesions but no more than 10 on each forearm or wrist
- Have fair skin type (Fitzpatrick I-II)
- Females must be post-menopausal and not on systemic hormone replacement therapy
- Able to understand the procedures and risks involved
You will not qualify if you...
- More than 10 actinic keratosis lesions on an extremity
- Large actinic keratosis lesions (grade 2-3+, hyperkeratotic)
- Very thick actinic keratosis lesions (greater than 3 mm)
- History of diabetes
- History of poor wound healing or scarring
- Large tattoos that interfere with the study
- Other serious health problems or skin diseases that may affect the study
- Received field therapies like efudex cream or photodynamic therapy to forearms/wrists within the past year
- Planning to leave the region within the next 5 years
- Allergy to xylocaine if topical anesthetic is needed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive fractionated laser resurfacing treatment on either their right or left forearm.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants are monitored for changes in actinic keratosis and non-melanoma skin cancers over time after treatment.
Periodic visits over 5 years for follow-up assessments
Trial Site Locations
Total: 1 location
1
Wright State Physicians
Fairborn, Ohio, United States, 45324
Actively Recruiting
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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