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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03906253
• Other study ID #: 06438
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Wright State University
• Contact: Manager, Clinical Research Operations
• Phone: 937-245-7500
• Email: pturesearch[@]wrightstatephysicians.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Aging
• Keratosis
• Keratosis, Actinic
• Non-Melanoma Skin Cancer

Intervention

Device:
• Fractionated Laser Resurfacing
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Locations

Country	Name	City	State
United States	Dayton VA Medical Center	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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