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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
VA Office of Research and Development
Study ID
NCT07648407
Status
Not Yet Recruiting

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Conditions

  • Actinic Keratosis
  • Nonmelanoma Skin Cancer

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Microneedling - Male
    Forearm treatment with microneedling
  • Experimental: Microneedling - Female
    Forearm treatment with microneedling
  • Experimental: Trichloroacetic acid peel - Male
    Forearm treatment with trichloroacetic acid peel
  • Experimental: Trichloroacetic acid peel - Female
    Forearm treatment with trichloroacetic acid peel

Primary Outcome Measure

Change From Baseline in the Number of Actinic Keratosis due to treatment. [ Time Frame: up to 4 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolisIndiana46202-2884
Matthew J Turner, MD
[email protected]
317-988-5000
Matthew J Turner, MD (PRINCIPAL_INVESTIGATOR)
Dayton VA Medical Center, Dayton, OHDaytonOhio45428
Jeffrey B Travers, MD
[email protected]
Craig A Rohan, MD
[email protected]

Find similar trials in Indianapolis, IN

By research site
Richard L. Roudebush VA Medical Center, Indianapolis, IN· Indianapolis, INDayton VA Medical Center, Dayton, OH· Dayton, OH

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