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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorWright State University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Uncontrolled Diabetes Mellitus

Not able to comprehend procedures or risks versus benefits

Pregnant or nursing

Large tattoos on forearms

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fractionated Laser Resurfacing

    Device

    A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Factionated Laser Resurfacing - Right ArmExperimental treatment 1 intervention
Group B: Factionated Laser Resurfacing - Left ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in the Number of Actinic Keratosis due to FLR treatment.

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

Time frame
up to 5 years
2

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.

Time frame
up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.