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NCT Number: NCT06428721

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

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.

Recruiting

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Key information

Conditions

Actinic Keratoses Aging Keratosis Keratosis, Actinic Neoplasms Non-Melanoma Skin Cancer Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location status: Recruiting

Location contact

Pharmacology Translational Unit

CONTACT

[email protected]

937-245-7500

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractionated Laser Resurfacing

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manager, Clinical Research Operations

CONTACT

[email protected]

937-245-7500

Regulatory Specialist

CONTACT

[email protected]

937-245-7500

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
May 24, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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