Actinic Keratosis, Nonmelanoma Skin Cancer
Conditions
Keywords
Nonmelanoma skin cancer, Actinic keratosis, Ultraviolet light, Microneedling, Chemical peel
Brief summary
The investigators' previous studies demonstrate geriatric subject skin responds differently to ultraviolet B (UVB) light compared to young subject skin, which contribute to increased rates of nonmelanoma skin cancer (NMSC) and actinic keratosis (AK) development in geriatric populations. Previously, the investigators have shown that therapeutic dermal remodeling interventions (e.g., fractionated laser resurfacing and microneedling) can restore appropriate skin responses to UVB in geriatric skin. The investigators also demonstrated fractionated laser resurfacing (FLR) reduced rates of NMSC and AK development (compared to untreated control skin) in at risk geriatric subjects. This interventional study will assess the ability of two therapeutic dermal remodeling therapies, microneedling and trichloroacetic acid chemical (TCA) peel, to impact NMSC and AK development in at risk geriatric subjects. Geriatric subjects will be enrolled into one of two study groups. In the first group, one arm will be treated with microneedling and the other arm will not be treated on day 1. In the second group, one arm will be treated with TCA peel and the other arm will not be treated on day 1. Subjects will subsequently be monitored for number of NMSC and AK on treated and untreated (control) forearms in each group. In addition to monitoring NMSC and AK development, subjects at the Richard L. Roudebush VAMC will undergo skin punch biopsy at one of their follow up visits for microscopic and molecular analyses of treated and untreated skin.
Interventions
OTHERMicroneedling
Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
Trichloroacetic acid peel that removes a superficial part of the skin
Sponsors
VA Office of Research and Development
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 age 60 and older with 5 or more AKs on each forearm * Skin type fair-Fitzpatrick I-II * Able to comprehend procedures and risks
Exclusion criteria
* More than 10 AKs on an extremity, or AKs that are large (2-3+) * Medical history of Diabetes * Coagulopathy or easy bleeding * 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 * Planning to leave region in next 4 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Number of Actinic Keratosis due to treatment. | up to 4 years | Investigator will assess the number of actinic keratosis on both forearms |
| Change From Baseline in the Number Non-Melanoma Skin Cancers due to treatment. | up to 4 years | Investigator will assess the number of nonmelanoma skin cancers on both forearms. |
Countries
United States
Contacts
CONTACTMatthew J Turner, MD
PRINCIPAL_INVESTIGATORMatthew J Turner, MD
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Outcome results
None listed