NCT06428721 · Wright State University
The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
What this study is about
The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic.
View original scientific description
The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.
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
Investigator will assess the number of actinic keratosis on both forearms at each visit.
Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.
Time frame: Up to 5 years
Investigator will assess the number of actinic keratosis on both forearms at each visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult Males and Females aged 60 and older
- Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
- Skin type fair (Fitzpatrick I-II)
- Females must be post-menopausal and not be on systemic hormone replacement therapy
- Able to comprehend procedures and risks
Exclusion criteria
- More than 10 AKs on an extremity
- AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
- AKs that are very thick (\>3 mm)
- Medical history of diabetes
- History of poor wound healing or scarring
- Large tattoos that can interfere with study
- Other serious health issues and other skin diseases that could interfere with the study
- Recent (within 1 year) field therapies such as efudex cream or PDT to forearms/wrists.
- Planning to leave region in next 5 years
- Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.
Where
- Fairborn, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2024 · Source of record for eligibility and locations