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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.