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NCT Number: NCT07648407

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microneedling

Other

Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin

Trichloroacetic acid peel

Other

Trichloroacetic acid peel that removes a superficial part of the skin

Primary outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew J Turner, MD

CONTACT

[email protected]

(317) 988-5000

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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