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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428721
• Other study ID #: 2023-346
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: December 2031

Study information

• Verified date: May 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2031
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

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