The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fractionated Laser Resurfacing.
- Who it may be relevant to
- Registry conditions: Actinic Keratoses, Aging, Non-Melanoma Skin Cancer. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Fractionated Laser Resurfacing
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment. [Time frame: Up to 5 years]
- Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment. [Time frame: Up to 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wright State Physicians — Fairborn
Identifiers
NCT: NCT06428721 · 2023-346