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

Not Applicable

Recruiting

• Conditions: Non-Melanoma Skin Cancer; Actinic Keratoses; Aging
• Interventions: Device: Fractionated Laser Resurfacing

• Registration Number: NCT06428721
• Lead Sponsor: Wright State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-20
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2031-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractionated Laser Resurfacing - Right Arm	Fractionated Laser Resurfacing	Right forearm treatment of fractionated laser resurfacing.
Fractionated Laser Resurfacing - Left Arm	Fractionated Laser Resurfacing	Left forearm treatment of fractionated laser resurfacing.

Primary Outcome Measures

Name	Time	Method
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 at each visit.
Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.	Up to 5 years	Investigator will assess the number of actinic keratosis on both forearms at each visit.

Secondary Outcome Measures

Name	Time	Method
Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.	Up to 5 years	Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.	Up to 5 years	Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States