Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation

June 9, 2026 updated by: VA Office of Research and Development

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN
        • Contact:
        • Principal Investigator:
          • Matthew J Turner, MD
    • Ohio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microneedling - Male
Forearm treatment with microneedling
Other: Microneedling
Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
Experimental: Microneedling - Female
Forearm treatment with microneedling
Other: Microneedling
Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
Experimental: Trichloroacetic acid peel - Male
Forearm treatment with trichloroacetic acid peel
Other: Trichloroacetic acid peel
Trichloroacetic acid peel that removes a superficial part of the skin
Experimental: Trichloroacetic acid peel - Female
Forearm treatment with trichloroacetic acid peel
Other: Trichloroacetic acid peel
Trichloroacetic acid peel that removes a superficial part of the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Number of Actinic Keratosis due to treatment.
Time Frame: up to 4 years
Investigator will assess the number of actinic keratosis on both forearms
up to 4 years
Change From Baseline in the Number Non-Melanoma Skin Cancers due to treatment.
Time Frame: up to 4 years
Investigator will assess the number of nonmelanoma skin cancers on both forearms.
up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Matthew J Turner, MD, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCE-003-25S
  • RD001084 (Other Grant/Funding Number: U.S. Veterans Administration)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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