Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Part of paid clinical trials in Dayton, Ohio.
- Sponsor
- Wright State University
- Study ID
- NCT03906253
- Status
- Recruiting
Conditions
- Actinic Keratoses
- Aging
- Non-Melanoma Skin Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fractionated Laser Resurfacing — DEVICEA rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Study Details
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.
Key Dates
- Start date
- Jan 10, 2018
- Status verified
- Mar 2025
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Factionated Laser Resurfacing - Right ArmRight forearm treatment of fractionated laser resurfacing.
- Experimental: Factionated Laser Resurfacing - Left ArmLeft forearm treatment of fractionated laser resurfacing.
Primary Outcome Measure
Change From Baseline in the Number of Actinic Keratosis due to FLR treatment. [ Time Frame: up to 5 years ]
Central Contacts
- Manager, Clinical Research Operations937-245-7500
- Regulatory Specialist937-245-7500
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dayton VA Medical Center | Dayton | Ohio | 45428 | - |
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