NCT03906253 · Wright State University
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
What this study is about
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.
View original scientific description
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
Investigator will assess the number of actinic keratosis on both forearms.
Change From Baseline in the Number 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.
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
- 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
Where
- Dayton, 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 Mar 25, 2025 · Source of record for eligibility and locations