Nonmelanoma Skin CancerNCT07648407
Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation
A study testing Microneedling and Trichloroacetic acid peel in people with Nonmelanoma Skin Cancer and Actinic Keratosis, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Nonmelanoma Skin Cancer, Actinic Keratosis
- What is being tested?
- Microneedling and Trichloroacetic acid peel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5 or more actinic keratosis (AKs) on each forearm
- Skin type fair-Fitzpatrick I-II
- Able to comprehend procedures and risks
Who cannot join
- 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
- 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 photodynamic therapy (PDT) to forearms
- Planning to leave region in next 4 years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, 45428
Jeffrey B Travers, MD, jeffrey.travers@va.gov
Craig A Rohan, MD, craig.rohan@va.gov
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
Matthew J Turner, MD, (317) 988-5000, matthew.turner@va.gov
Matthew J Turner, MD
About this study
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
- Being tested
- Microneedling, Trichloroacetic acid peel
- Keywords
- Nonmelanoma skin cancer, Actinic keratosis, Ultraviolet light, Microneedling, Chemical peel
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedlingOther
Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
Trichloroacetic acid peelOther
Trichloroacetic acid peel that removes a superficial part of the skin
| Study group | Role | What they receive |
|---|---|---|
| Microneedling - Male | Experimental | Forearm treatment with microneedling Receives: Other: Microneedling |
| Microneedling - Female | Experimental | Forearm treatment with microneedling Receives: Other: Microneedling |
| Trichloroacetic acid peel - Male | Experimental | Forearm treatment with trichloroacetic acid peel Receives: Other: Trichloroacetic acid peel |
| Trichloroacetic acid peel - Female | Experimental | Forearm treatment with trichloroacetic acid peel Receives: Other: Trichloroacetic acid peel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Number of Actinic Keratosis due to treatment.
Investigator will assess the number of actinic keratosis on both forearms
Measured: 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.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonmelanoma Skin CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew J Turner, MD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648407
- Sponsor's protocol ID
- ONCE-003-25S
- Other IDs
- RD001084
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation
- ClinicalTrials.gov ID
- NCT07648407
- Acronym / sponsor ID
- ONCE-003-25S
- Conditions
- Nonmelanoma Skin Cancer, Actinic Keratosis
- Keywords
- Nonmelanoma skin cancer, Actinic keratosis, Ultraviolet light, Microneedling, Chemical peel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Microneedling - Male | Experimental | Other: MicroneedlingForearm treatment with microneedling |
| Microneedling - Female | Experimental | Other: MicroneedlingForearm treatment with microneedling |
| Trichloroacetic acid peel - Male | Experimental | Other: Trichloroacetic acid peelForearm treatment with trichloroacetic acid peel |
| Trichloroacetic acid peel - Female | Experimental | Other: Trichloroacetic acid peelForearm treatment with trichloroacetic acid peel |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 5 or more actinic keratosis (AKs) on each forearm
- Skin type fair-Fitzpatrick I-II
- Able to comprehend procedures and risks
Key exclusion criteria (8 listed)
- 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
- Large tattoos that can interfere with study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroneedlingMicroneedling- a mechanical tool that makes tiny holes in a superficial part of the skin | Other | Microneedling - Female, Microneedling - Male |
| Trichloroacetic acid peelTrichloroacetic acid peel that removes a superficial part of the skin | Other | Trichloroacetic acid peel - Female, Trichloroacetic acid peel - Male |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew J Turner, MD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling and Trichloroacetic acid peel in people with Nonmelanoma Skin Cancer and Actinic Keratosis, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew J Turner, MD ((317) 988-5000, matthew.turner@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Number of Actinic Keratosis due to treatment. (time frame: up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.