## Protocol Section
### Identification Module
**NCT ID:** NCT06428721

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

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

#### Organization Study ID Info
**ID:** 2023-346
#### Organization
**Class:** OTHER
**Full Name:** Wright State University
### Status Module
#### Completion Date
**Date:** 2031-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2031-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wright State University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Actinic Keratoses

- Aging

- Non-Melanoma Skin Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Right forearm treatment of fractionated laser resurfacing.

**Intervention Names:**

- Device: Fractionated Laser Resurfacing

**Label:** Fractionated Laser Resurfacing - Right Arm

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Left forearm treatment of fractionated laser resurfacing.

**Intervention Names:**

- Device: Fractionated Laser Resurfacing

**Label:** Fractionated Laser Resurfacing - Left Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fractionated Laser Resurfacing - Left Arm

- Fractionated Laser Resurfacing - Right Arm

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

**Name:** Fractionated Laser Resurfacing

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Change from baseline in the number of actinic keratosis due to FLR treatment.

**Time Frame:** Up to 5 years

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

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

**Time Frame:** Up to 5 years

#### Secondary Outcomes

**Description:** Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.

**Measure:** Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.

**Time Frame:** Up to 5 years

**Description:** Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.

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

**Time Frame:** Up to 5 years

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** pturesearch@wrightstatephysicians.org

**Name:** Manager, Clinical Research Operations

**Phone:** 937-245-7500

**Role:** CONTACT

**Contact 2:**

**Email:** pturesearch@wrightstatephysicians.org

**Name:** Regulatory Specialist

**Phone:** 937-245-7500

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fairborn

**Contacts:**

***Contact 1:***

- **Email:** pturesearch@wrightstatephysicians.org

- **Name:** Pharmacology Translational Unit

- **Phone:** 937-245-7500

- **Role:** CONTACT

**Country:** United States

**Facility:** Wright State Physicians

**State:** Ohio

**Status:** RECRUITING

**Zip:** 45324

#### Overall Officials

**Official 1:**

**Affiliation:** Wright State University

**Name:** Jeffrey Travers, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000012871

- Term: Skin Diseases

- ID: D000011230

- Term: Precancerous Conditions

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M28268

- Name: Keratosis, Actinic

- Relevance: HIGH

- As Found: Actinic Keratosis

- ID: M10668

- Name: Keratosis

- Relevance: HIGH

- As Found: Keratosis

- ID: M15681

- Name: Skin Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14111

- Name: Precancerous Conditions

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055623

- Term: Keratosis, Actinic

- ID: D000007642

- Term: Keratosis

### Misc Info Module

- Version Holder: 2024-05-31
