The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population

July 14, 2026 updated by: Wright State University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractionated Laser Resurfacing - Right Arm
Right forearm treatment of fractionated laser resurfacing.
Device: Fractionated Laser Resurfacing
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Experimental: Fractionated Laser Resurfacing - Left Arm
Left forearm treatment of fractionated laser resurfacing.
Device: Fractionated Laser Resurfacing
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
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.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.
Time Frame: Up to 5 years
Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
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
Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wright State University

Investigators

  • Principal Investigator: Jeffrey Travers, MD, PhD, Wright State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2024

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-346

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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