The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population

NCT06428721 | Recruiting FDA Device

• 1 other identifier: 2023-346
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.

Conditions

Actinic Keratoses; Aging; Non-Melanoma Skin Cancer

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the number of actinic keratosis due to FLR treatment.

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

  Up to 5 years

• Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.

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

  Up to 5 years

Secondary Outcomes (2)

• Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.

  Up to 5 years

• Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.

  Up to 5 years

Study Arms (2)

Fractionated Laser Resurfacing - Right Arm

EXPERIMENTAL

Right forearm treatment of fractionated laser resurfacing.

Device: Fractionated Laser Resurfacing

Fractionated Laser Resurfacing - Left Arm

EXPERIMENTAL

Left forearm treatment of fractionated laser resurfacing.

Device: Fractionated Laser Resurfacing

Interventions

Fractionated Laser Resurfacing DEVICE

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

Fractionated Laser Resurfacing - Left Arm; Fractionated Laser Resurfacing - Right Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Males and Females aged 60 and older
• Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
• Skin type fair (Fitzpatrick I-II)
• Females must be post-menopausal and not be on systemic hormone replacement therapy
• Able to comprehend procedures and risks

You may not qualify if:

• More than 10 AKs on an extremity
• AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
• AKs that are very thick (\>3 mm)
• Medical history of diabetes
• History of poor wound healing or scarring
• Large tattoos that can interfere with study
• Other serious health issues and other skin diseases that could interfere with the study
• Recent (within 1 year) field therapies such as efudex cream or PDT to forearms/wrists.
• Planning to leave region in next 5 years
• Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeffrey Travers, MD, PhD

  Wright State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manager, Clinical Research Operations

CONTACT

937-245-7500; pturesearch@wrightstatephysicians.org

Regulatory Specialist

CONTACT

937-245-7500; pturesearch@wrightstatephysicians.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

US (1)