Actinic Keratoses, Aging, Non-Melanoma Skin Cancer
Conditions
Brief summary
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
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Sponsors
Wright State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the number of actinic keratosis due to FLR treatment. | 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. | Up to 5 years | Investigator will assess the number of actinic keratosis on both forearms at each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment. | Up to 5 years | Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit. |
| Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment. | Up to 5 years | Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit. |
Countries
United States
Contacts
CONTACTManager, Clinical Research Operations
CONTACTRegulatory Specialist
PRINCIPAL_INVESTIGATORJeffrey Travers, MD, PhD
Wright State University
Outcome results
None listed