The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
Recruiting · NCT06428721 · Interventional (participants receive a specific treatment) · Lead sponsor: Wright State University
View the official record on ClinicalTrials.gov →Interventions studied
Fractionated Laser Resurfacing
What this trial 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. 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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Wright State Physicians - Fairborn, Ohio, United States