Microneedling + TCA Peel for Actinic Keratosis and Skin Cancer

Not yet recruiting at 1 trial location
MJ
Overseen ByMatthew J Turner, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MJ

Matthew J Turner, MD

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Are You a Good Fit for This Trial?

This trial is for older adults (geriatric individuals), especially veterans, who are at risk of developing actinic keratosis or nonmelanoma skin cancer due to long-term sun exposure. Participants should not have conditions that would prevent them from safely undergoing skin treatments.

Inclusion Criteria

I understand the study procedures and risks.
I am 60 or older and have at least 5 AKs on each forearm.
Skin type fair-Fitzpatrick I-II

Exclusion Criteria

I have more than 10 or several large actinic keratoses on my arm or leg.
I have a history of diabetes.
I have a bleeding disorder or bleed easily.
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • Microneedling
  • Trichloroacetic acid peel

Trial Overview

The study compares two skin treatments—microneedling and trichloroacetic acid (TCA) chemical peel—to see if they can help prevent precancerous and cancerous skin growths on the arms of older adults exposed to a lot of sunlight. Each participant has one arm treated while the other serves as a control.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Trichloroacetic acid peel - MaleExperimental Treatment1 Intervention
Group II: Trichloroacetic acid peel - FemaleExperimental Treatment1 Intervention
Group III: Microneedling - MaleExperimental Treatment1 Intervention
Group IV: Microneedling - FemaleExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+