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

NCT ID: NCT06428721

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2031-12-31

Brief Summary

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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

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Conditions

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Actinic Keratoses Aging Non-Melanoma Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fractionated Laser Resurfacing - Right Arm

Right forearm treatment of fractionated laser resurfacing.

Group Type EXPERIMENTAL

Fractionated Laser Resurfacing

Intervention Type DEVICE

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

Fractionated Laser Resurfacing - Left Arm

Left forearm treatment of fractionated laser resurfacing.

Group Type EXPERIMENTAL

Fractionated Laser Resurfacing

Intervention Type DEVICE

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

Interventions

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Fractionated Laser Resurfacing

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wright State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State University

Locations

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Wright State Physicians

Fairborn, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Manager, Clinical Research Operations

Role: CONTACT

937-245-7500

Regulatory Specialist

Role: CONTACT

937-245-7500

Facility Contacts

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Pharmacology Translational Unit

Role: primary

937-245-7500

Other Identifiers

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2023-346

Identifier Type: -

Identifier Source: org_study_id

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