Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Primary Purpose
Actinic Keratoses, Aging, Non-Melanoma Skin Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractionated Laser Resurfacing
Sponsored by
About this trial
This is an interventional prevention trial for Actinic Keratoses
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Actinic Keratosis within the past 6 months
- At least 60 years of age, or older
- Ability to comprehend procedures and risks versus benefits
- Able to provide Informed Consent
- Fair Skin (Fitzpatrick Type I or II)
- Possess both Right and Left Forearms
Exclusion Criteria:
- Uncontrolled Diabetes Mellitus
- Not able to comprehend procedures or risks versus benefits
- Pregnant or nursing
- Large tattoos on forearms
- History of abnormal healing or scarring (i.e., keloids)
- Any disease that gets worse while in the sun
- Use of topical or oral anti-inflammatory medication or steroids
- Allergy to lidocaine
- Current use of photosensitizing medication
Sites / Locations
- Dayton VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Factionated Laser Resurfacing - Right Arm
Factionated Laser Resurfacing - Left Arm
Arm Description
Right forearm treatment of fractionated laser resurfacing.
Left forearm treatment of fractionated laser resurfacing.
Outcomes
Primary Outcome Measures
Change From Baseline in the Number of Actinic Keratosis due to FLR treatment.
Investigator will assess the number of actinic keratosis on both forearms.
Change From Baseline in the Number Non-Melanoma Skin Cancers due to FLR treatment.
Investigator will assess the number of actinic keratosis on both forearms.
Secondary Outcome Measures
Full Information
NCT ID
NCT03906253
First Posted
April 4, 2019
Last Updated
February 22, 2023
Sponsor
Wright State University
1. Study Identification
Unique Protocol Identification Number
NCT03906253
Brief Title
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Official Title
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wright State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is following up on previous studies that have demonstrated that geriatric subjects respond different to ultraviolet B (UVB) light than young subjects. The treatment of geriatric skin with dermal rejuvenation therapies (dermabrasion, fractionated laser resurfacing) restores the appropriate UVB response. Ongoing studies have tested the ability of fractionated laser resurfacing (FLR) to assess how long this wounding effect lasts-and have found that this appears to be a durable response which lasts for at least two years. The findings that FLR protects geriatric skin at two years is the impetus for this study.
This study is an interventional study to assess if FLR treatment of one forearm of geriatric subjects with multiple actinic keratosis will result in the short-term removal of actinic keratosis, and the long-term decrease in levels of future actinic keratosis and other non-melanoma skin cancers in comparison to the untreated arm.
Study length and visit: The first part of the study is completed in 1 day then there are follow up visits at 90 days and every 6 months for 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses, Aging, Non-Melanoma Skin Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Factionated Laser Resurfacing - Right Arm
Arm Type
Experimental
Arm Description
Right forearm treatment of fractionated laser resurfacing.
Arm Title
Factionated Laser Resurfacing - Left Arm
Arm Type
Experimental
Arm Description
Left forearm treatment of fractionated laser resurfacing.
Intervention Type
Device
Intervention Name(s)
Fractionated Laser Resurfacing
Intervention Description
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Actinic Keratosis due to FLR treatment.
Description
Investigator will assess the number of actinic keratosis on both forearms.
Time Frame
up to 5 years
Title
Change From Baseline in the Number Non-Melanoma Skin Cancers due to FLR treatment.
Description
Investigator will assess the number of actinic keratosis on both forearms.
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Actinic Keratosis within the past 6 months
At least 60 years of age, or older
Ability to comprehend procedures and risks versus benefits
Able to provide Informed Consent
Fair Skin (Fitzpatrick Type I or II)
Possess both Right and Left Forearms
Exclusion Criteria:
Uncontrolled Diabetes Mellitus
Not able to comprehend procedures or risks versus benefits
Pregnant or nursing
Large tattoos on forearms
History of abnormal healing or scarring (i.e., keloids)
Any disease that gets worse while in the sun
Use of topical or oral anti-inflammatory medication or steroids
Allergy to lidocaine
Current use of photosensitizing medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manager, Clinical Research Operations
Phone
937-245-7500
Email
pturesearch@wrightstatephysicians.org
First Name & Middle Initial & Last Name or Official Title & Degree
Regulatory Specialist
Phone
937-245-7500
Email
pturesearch@wrightstatephysicians.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey B Travers, MD, PhD
Organizational Affiliation
Wright State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dayton VA Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
34428179
Citation
Spandau DF, Chen R, Wargo JJ, Rohan CA, Southern D, Zhang A, Loesch M, Weyerbacher J, Tholpady SS, Lewis DA, Kuhar M, Tsai KY, Castellanos AJ, Kemp MG, Markey M, Cates E, Williams AR, Knisely C, Bashir S, Gabbard R, Hoopes R, Travers JB. Randomized controlled trial of fractionated laser resurfacing on aged skin as prophylaxis against actinic neoplasia. J Clin Invest. 2021 Oct 1;131(19):e150972. doi: 10.1172/JCI150972.
Results Reference
derived
PubMed Identifier
31736123
Citation
Chen R, Wargo JJ, Williams A, Cates E, Spandau DF, Knisely C, Travers JB. Single Ablative Fractional Resurfacing Laser Treatment For Forearm Actinic Keratoses: 6-Month Follow-Up Data From An Intrapatient Comparison Between Treated and Untreated Sites. Lasers Surg Med. 2020 Jan;52(1):84-87. doi: 10.1002/lsm.23175. Epub 2019 Nov 17.
Results Reference
derived
Learn more about this trial
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
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