Recruiting

Fractionated Laser Resurfacing

Sponsor:

Wright State University

Code:

NCT06428721

Conditions

Actinic Keratoses

Aging

Non-Melanoma Skin Cancer

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Fractionated Laser Resurfacing

Study Details

Brief 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. 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

Study ID

NCT06428721

Start date

Mar 20, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Fractionated Laser Resurfacing - Right Arm

Right forearm treatment of fractionated laser resurfacing.

experimental: Fractionated Laser Resurfacing - Left Arm

Left forearm treatment of fractionated laser resurfacing.

Interventions

Fractionated Laser Resurfacing

A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Primary outcome measure

  • Change from baseline in the number of actinic keratosis due to FLR treatment. [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Manager, Clinical Research Operations

937-245-7500pturesearch@wrightstatephysicians.org

Regulatory Specialist

937-245-7500pturesearch@wrightstatephysicians.org

Locations

Wright State Physicians

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Pharmacology Translational Unit

937-245-7500pturesearch@wrightstatephysicians.org

More Information

Sponsor

Wright State University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wright State University on 2026-07-16.