NCT03906253 Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
| NCT ID | NCT03906253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wright State University |
| Condition | Actinic Keratoses |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2018-01-10 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2018-01-10 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jeffrey B Travers, MD, PhD
PRINCIPAL INVESTIGATOR
Wright State University
Frequently Asked Questions
Who can join the NCT03906253 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Actinic Keratoses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03906253 currently recruiting?
Yes, NCT03906253 is actively recruiting participants. Contact the research team at pturesearch@wrightstatephysicians.org for enrollment information.
Where is the NCT03906253 trial being conducted?
This trial is being conducted at Dayton, United States.
Who is sponsoring the NCT03906253 clinical trial?
NCT03906253 is sponsored by Wright State University. The principal investigator is Jeffrey B Travers, MD, PhD at Wright State University. The trial plans to enroll 72 participants.