Microneedling + TCA Peel for Actinic Keratosis and Skin Cancer

Not yet recruiting at 1 trial location
MJ
Overseen ByMatthew J Turner, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two skin treatments—microneedling and a trichloroacetic acid (TCA) peel—can reduce the risk of developing nonmelanoma skin cancer (NMSC) and actinic keratosis (AK), common skin issues in older adults. Participants will receive treatment on one arm while the other arm remains untreated, allowing researchers to compare the effects. Ideal candidates for this study have at least five small, rough patches known as actinic keratosis on each forearm, fair skin, and the ability to understand the study process. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on skin cancer prevention.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that microneedling and trichloroacetic acid (TCA) peels are generally safe for treating skin conditions like actinic keratosis (AK), which are rough, scaly patches that can potentially lead to skin cancer.

Microneedling involves using tiny needles to create small injuries in the skin, promoting healing and maintaining skin health. Patients have generally tolerated it well, experiencing only minor side effects.

TCA peels use a chemical solution to remove damaged skin layers. Commonly used in dermatology, they have proven safe in clinical settings. However, higher concentrations of TCA can increase the risk of side effects such as scarring or skin discoloration.

Overall, both treatments are considered safe with manageable side effects when used correctly.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using microneedling and trichloroacetic acid (TCA) peels for treating actinic keratosis and skin cancer because these methods offer unique benefits. Unlike standard treatments like cryotherapy or topical chemotherapy, microneedling boosts skin regeneration by creating micro-injuries that stimulate collagen production. Meanwhile, TCA peels work by deeply exfoliating the skin, which helps remove precancerous cells and encourages healthy skin renewal. This combination has the potential to enhance treatment effectiveness and improve skin texture more efficiently than traditional methods.

What evidence suggests that this trial's treatments could be effective for actinic keratosis and skin cancer?

This trial will compare the effects of microneedling and trichloroacetic acid (TCA) peels on skin health. Research has shown that microneedling can improve skin health by repairing and reshaping the skin's inner layer. This improvement helps the skin better handle UVB light, which is linked to nonmelanoma skin cancer (NMSC) and actinic keratosis (AK). Studies have demonstrated that treatments like fractionated laser resurfacing can lower the rates of NMSC and AK, suggesting microneedling might offer similar benefits.

TCA peels, on the other hand, deeply exfoliate the skin, removing damaged outer layers. This process can potentially reduce the number of AK lesions by encouraging the growth of new, healthier skin. Although specific data on TCA peels for preventing NMSC or AK is limited, their mechanism suggests they could help reduce precancerous skin changes. Both treatments aim to improve skin health, potentially lowering cancer risks. Participants in this trial will receive either microneedling or TCA peel treatment to assess their effectiveness in reducing precancerous skin changes.678910

Who Is on the Research Team?

MJ

Matthew J Turner, MD

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Are You a Good Fit for This Trial?

This trial is for older adults (geriatric individuals), especially veterans, who are at risk of developing actinic keratosis or nonmelanoma skin cancer due to long-term sun exposure. Participants should not have conditions that would prevent them from safely undergoing skin treatments.

Inclusion Criteria

I understand the study procedures and risks.
I am 60 or older and have at least 5 AKs on each forearm.
Skin type fair-Fitzpatrick I-II

Exclusion Criteria

I have more than 10 or several large actinic keratoses on my arm or leg.
I have a history of diabetes.
I have a bleeding disorder or bleed easily.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive microneedling or trichloroacetic acid peel treatment on one forearm, with the other forearm serving as a control

1 day
1 visit (in-person)

Follow-up

Participants are monitored for the development of actinic keratosis and nonmelanoma skin cancers, with skin punch biopsies conducted at one of the follow-up visits

up to 4 years
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Microneedling
  • Trichloroacetic acid peel

Trial Overview

The study compares two skin treatments—microneedling and trichloroacetic acid (TCA) chemical peel—to see if they can help prevent precancerous and cancerous skin growths on the arms of older adults exposed to a lot of sunlight. Each participant has one arm treated while the other serves as a control.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Trichloroacetic acid peel - MaleExperimental Treatment1 Intervention
Group II: Trichloroacetic acid peel - FemaleExperimental Treatment1 Intervention
Group III: Microneedling - MaleExperimental Treatment1 Intervention
Group IV: Microneedling - FemaleExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

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