Actinic KeratosesNCT06428721
The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
A study testing Fractionated Laser Resurfacing in people with Actinic Keratoses and Aging, run by Wright State University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Actinic Keratoses, Aging, Non-Melanoma Skin Cancer
- What is being tested?
- Fractionated Laser Resurfacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to Dec 2031
- 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
- Adult Males and Females aged 60 and older
- Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
- Skin type fair (Fitzpatrick I-II)
- Females must be post-menopausal and not be on systemic hormone replacement therapy
- Able to comprehend procedures and risks
Who cannot join
- More than 10 AKs on an extremity
- AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
- AKs that are very thick (>3 mm)
- Medical history of diabetes
- History of poor wound healing or scarring
- Large tattoos that can interfere with study
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- 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/wrists.
- Planning to leave region in next 5 years
- Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wright State Physicians
Fairborn, Ohio, 45324
Pharmacology Translational Unit, 937-245-7500, pturesearch@wrightstatephysicians.org
About this study
The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.
- Conditions
- Actinic Keratoses, Aging, Non-Melanoma Skin Cancer
- Being tested
- Fractionated Laser Resurfacing
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Laser ResurfacingDevice
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Fractionated Laser Resurfacing - Right Arm | Experimental | Right forearm treatment of fractionated laser resurfacing. Receives: Device: Fractionated Laser Resurfacing |
| Fractionated Laser Resurfacing - Left Arm | Experimental | Left forearm treatment of fractionated laser resurfacing. Receives: Device: Fractionated Laser Resurfacing |
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 FLR treatment.
Investigator will assess the number of actinic keratosis on both forearms at each visit.
Measured: Up to 5 years
Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.
Investigator will assess the number of actinic keratosis on both forearms at each visit.
Measured: Up to 5 years
Secondary outcomes (2)
Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.
Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
Measured: Up to 5 years
Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.
Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start20 Mar 2024
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Travers, MD, PhD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428721
- Sponsor's protocol ID
- 2023-346
- Status last verified
- Jul 2026
- First submitted
- 20 May 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
- ClinicalTrials.gov ID
- NCT06428721
- Acronym / sponsor ID
- 2023-346
- Conditions
- Actinic Keratoses, Aging, Non-Melanoma Skin Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 24 May 2024 (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 purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractionated Laser Resurfacing - Right Arm | Experimental | Device: Fractionated Laser ResurfacingRight forearm treatment of fractionated laser resurfacing. |
| Fractionated Laser Resurfacing - Left Arm | Experimental | Device: Fractionated Laser ResurfacingLeft forearm treatment of fractionated laser resurfacing. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult Males and Females aged 60 and older
- Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
- Skin type fair (Fitzpatrick I-II)
- Females must be post-menopausal and not be on systemic hormone replacement therapy
- Able to comprehend procedures and risks
Key exclusion criteria (10 listed)
- More than 10 AKs on an extremity
- AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
- AKs that are very thick (>3 mm)
- Medical history of diabetes
- History of poor wound healing or scarring
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 |
|---|---|---|
| Fractionated Laser ResurfacingA rejuvenating laser that makes tiny holes in the very superficial part of the skin. | Device | Fractionated Laser Resurfacing - Left Arm, Fractionated Laser Resurfacing - Right Arm |
Primary outcome
Change from baseline in the number of actinic keratosis due to FLR treatment.
Time frame: Up to 5 years
Investigator will assess the number of actinic keratosis on both forearms at each visit.
Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.
Time frame: Up to 5 years
Investigator will assess the number of actinic keratosis on both forearms at each visit.
2 secondary outcomes
Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.
Time frame: Up to 5 years
Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.
Time frame: Up to 5 years
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 16 Jul 2026.
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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.
Jeffrey Travers, MD, PhD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Laser Resurfacing in people with Actinic Keratoses and Aging, run by Wright State University at 1 site 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Manager, Clinical Research Operations (937-245-7500, pturesearch@wrightstatephysicians.org), 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 FLR treatment. (time frame: Up to 5 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 16 Jul 2026.