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
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