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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Factionated Laser Resurfacing - Right Arm | Experimental | Right forearm treatment of fractionated laser resurfacing. |
|
| Factionated Laser Resurfacing - Left Arm | Experimental | Left forearm treatment of fractionated laser resurfacing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated Laser Resurfacing | Device | A rejuvenating laser that makes tiny holes in the very superficial part of the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Actinic Keratosis due to FLR treatment. | Investigator will assess the number of actinic keratosis on both forearms. | up to 5 years |
| 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. | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Research Operations | Contact | 937-245-7500 | pturesearch@wrightstatephysicians.org | |
| Regulatory Specialist | Contact | 937-245-7500 | pturesearch@wrightstatephysicians.org |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Travers, MD, PhD | Wright State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dayton VA Medical Center | Recruiting | Dayton | Ohio | 45428 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34428179 | Derived | 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. | |
| 31736123 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2023 | Feb 22, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| Derived |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |