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

Purpose

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

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Wright State Physicians
Fairborn, Ohio 45324
Contact:
Pharmacology Translational Unit
937-245-7500
pturesearch@wrightstatephysicians.org

More Details

Status
Recruiting
Sponsor
Wright State University

Study Contact

Manager, Clinical Research Operations
937-245-7500
pturesearch@wrightstatephysicians.org