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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVA Office of Research and Development

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

5 or more actinic keratosis (AKs) on each forearm

Skin type fair-Fitzpatrick I-II

Able to comprehend procedures and risks

Disqualifiers

More than 10 actinic keratosis (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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microneedling

    Other intervention

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

  • Trichloroacetic acid peel

    Other intervention

    Trichloroacetic acid peel that removes a superficial part of the skin

Treatment groups

96 Participants
are divided into 4 treatment groups
Group A: Microneedling - MaleExperimental treatment 1 intervention
Group B: Microneedling - FemaleExperimental treatment 1 intervention
Group C: Trichloroacetic acid peel - MaleExperimental treatment 1 intervention
Group D: Trichloroacetic acid peel - FemaleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Investigator will assess the number of actinic keratosis on both forearms

Time frame
up to 4 years
2

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.

Time frame
up to 4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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