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Trial Title:
The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
NCT ID:
NCT06428721
Condition:
Actinic Keratoses
Aging
Non-Melanoma Skin Cancer
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Fractionated Laser Resurfacing
Description:
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Arm group label:
Fractionated Laser Resurfacing - Left Arm
Arm group label:
Fractionated Laser Resurfacing - Right Arm
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.
Criteria for 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.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wright State Physicians
Address:
City:
Fairborn
Zip:
45324
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pharmacology Translational Unit
Phone:
937-245-7500
Email:
pturesearch@wrightstatephysicians.org
Start date:
March 20, 2024
Completion date:
December 2031
Lead sponsor:
Agency:
Wright State University
Agency class:
Other
Source:
Wright State University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06428721
