The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Actinic Keratoses
- Sponsor
- Wright State University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from baseline in the number of actinic keratosis due to FLR treatment.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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
- Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.(Up to 5 years)
- Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.(Up to 5 years)