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

NCT07648407 | Not Yet Recruiting DMC

• 2 other identifiers: ONCE-003-25SRD001084
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Nonmelanoma Skin Cancer; Actinic Keratosis

Keywords

Nonmelanoma skin cancer; Actinic keratosis; Ultraviolet light; Microneedling; Chemical peel

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Number of Actinic Keratosis due to treatment.

  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.

  Investigator will assess the number of nonmelanoma skin cancers on both forearms.

  up to 4 years

Study Arms (4)

Microneedling - Male

EXPERIMENTAL

Forearm treatment with microneedling

Other: Microneedling

Microneedling - Female

EXPERIMENTAL

Forearm treatment with microneedling

Other: Microneedling

Trichloroacetic acid peel - Male

EXPERIMENTAL

Forearm treatment with trichloroacetic acid peel

Other: Trichloroacetic acid peel

Trichloroacetic acid peel - Female

EXPERIMENTAL

Forearm treatment with trichloroacetic acid peel

Other: Trichloroacetic acid peel

Interventions

Microneedling OTHER

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

Microneedling - Female; Microneedling - Male

Trichloroacetic acid peel OTHER

Trichloroacetic acid peel that removes a superficial part of the skin

Trichloroacetic acid peel - Female; Trichloroacetic acid peel - Male

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Dayton VA Medical Center, Dayton, OH

Dayton, Ohio, 45428, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Matthew J Turner, MD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew J Turner, MD

CONTACT

(317) 988-5000; matthew.turner@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)