Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03906253

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dayton VA Medical Center

Dayton, Ohio, 45428, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractionated Laser Resurfacing

Device

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

Primary outcomes

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

    Time frame: 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.

    Time frame: up to 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Manager, Clinical Research Operations

CONTACT

[email protected]

937-245-7500

Regulatory Specialist

CONTACT

[email protected]

937-245-7500

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2019
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.