Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia

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الحالةتجنيد

الرعاة

Jeffrey B. Travers, MD, PhD

تجربة سريرية: NCT03906253

BioSeek: nct03906253

الكلمات الدالة

نبذة مختصرة

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 geriatic 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.

تواريخ

آخر التحقق:	12/31/2019
تم الإرسال لأول مرة:	04/03/2019
تم إرسال التسجيل المقدر:	04/04/2019
أول نشر:	04/07/2019
تم إرسال آخر تحديث:	01/26/2020
آخر تحديث تم نشره:	01/28/2020
تاريخ بدء الدراسة الفعلي:	01/09/2018
تاريخ الإنجاز الأساسي المقدر:	11/30/2025
التاريخ المتوقع لانتهاء الدراسة:	11/30/2025

حالة أو مرض

Actinic Keratoses

Aging

Non-Melanoma Skin Cancer

التدخل / العلاج

Device: Fractionated Laser Resurfacing

مرحلة

مجموعات الذراع

ذراع	التدخل / العلاج
Experimental: Factionated Laser Resurfacing - Right Arm Right forearm treatment of fractionated laser resurfacing.
Experimental: Factionated Laser Resurfacing - Left Arm Left forearm treatment of fractionated laser resurfacing.

معايير الأهلية

الأعمار المؤهلة للدراسة	60 Years إلى 60 Years
الأجناس المؤهلة للدراسة	All
يقبل المتطوعين الأصحاء	نعم
المعايير	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

النتيجة

مقاييس النتائج الأولية

1. Change From Baseline in the Number of Actinic Keratosis due to FLR treatment. [up to 5 years]

Investigator will assess the number of actinic keratosis on both forearms.

2. Change From Baseline in the Number Non-Melanoma Skin Cancers due to FLR treatment. [up to 5 years]

Investigator will assess the number of actinic keratosis on both forearms.

Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia

الكلمات الدالة

سرطان الجلد

سرطان

ورم ميلانيني

تقران

مكافحة الشيخوخة