Effects of Simulated Solar Radiation on Human Skin in Preventing Skin Cancer

Effects of Simulated Solar Radiation on Human Skin

This clinical trial examines the effects of simulated solar radiation on human skin in preventing skin cancer. Testing whether new drugs affect biomarkers in the skin is a good first test of whether the drug might prevent skin cancer. Some biomarkers in skin, and even in moles, are affected after a person is exposed to sunlight. This study may help doctors learn more about what happens to the skin and moles when the participants are exposed to the sun.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Procedure: Physical Examination; Other: Solar Simulated Light

Detailed Description

PRIMARY OBJECTIVE:

I. To identify biomarkers of simulated solar radiation (SSR) treatment in human skin that can be used as surrogate endpoints in chemoprevention trials in humans.

SECONDARY OBJECTIVE:

I. Measure Langerhans cell (LC) and sunburn cell density in the epidermis, as well as deoxyribonucleic acid (DNA) damage.

EXPLORATORY OBJECTIVE I. To perform gene expression analysis on tissue frozen after biopsy.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 3 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.

GROUP II: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 4 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.

GROUP III: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 6 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 18-100 years. The investigators anticipate recruiting few if any patients over age 80 as nevi tend to disappear as people age. Both men and women of all races and ethnic groups will be included
• Participants must have 2 clinically benign melanocytic nevi 3-5 mm in diameter confirmed by clinical dermatoscopic examination by a medically-qualified study team member and suitable for biopsy (i.e. not at a site that would be functionally or cosmetically damaged by the biopsy). The minimum size restriction arises from the need for collection of tissue sufficient for single nucleus ribonucleic acid sequencing (RNAseq) analysis. The maximum size is dictated by the requirement that the entire nevus be removed with a 6 mm punch biopsy, thereby eliminating any concerns that might arise from regrowth of the nevus that can happen after incomplete removal
• All participants must be able to understand and be willing to sign a written informed consent document

Exclusion Criteria:

• Undergoing systemic therapy for melanoma or any other cancer
• Sensitivity to anesthetic agent
• Photosensitivity
• Currently taking supplements such as nicotinamide or antioxidants that might protect from skin cancer or alter the response of their skin to simulated solar radiation (SSR)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (low dose simulated sunlight); Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 3 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.	Procedure: Physical Examination; Undergo total body exam; Other Names: Assessment; General Examination; Physical; Physical Assessment; Physical Exam; physical_exam; Other: Solar Simulated Light; Undergo exposures to simulated sunlight; Other Names: Artificial Sunlight; Full-Spectrum Lighting; Solar Simulated Radiation; SSR
Experimental: Group II (middle dose simulated sunlight); Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 4 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.	Procedure: Physical Examination; Undergo total body exam; Other Names: Assessment; General Examination; Physical; Physical Assessment; Physical Exam; physical_exam; Other: Solar Simulated Light; Undergo exposures to simulated sunlight; Other Names: Artificial Sunlight; Full-Spectrum Lighting; Solar Simulated Radiation; SSR
Experimental: Group III (high dose simulated sunlight); Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 6 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.	Procedure: Physical Examination; Undergo total body exam; Other Names: Assessment; General Examination; Physical; Physical Assessment; Physical Exam; physical_exam; Other: Solar Simulated Light; Undergo exposures to simulated sunlight; Other Names: Artificial Sunlight; Full-Spectrum Lighting; Solar Simulated Radiation; SSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of pixels positive for p53 by immunohistochemical analysis	Will use immunohistochemical (IHC) analysis of biopsies to determine the difference between the percentage of pixels classified as positive or strong positive for p53 in irradiated nevi (moles) and unirradiated control nevi from each participant. Difference will be measured in percentage points ranging from 0 to 100 with no transformation prior to analysis.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deoxyribonucleic acid (DNA) damage	Will use IHC analysis of biopsies to examine the difference between the percentage of nuclei in 3 high-powered fields classified as positive or strong positive for cyclobutane pyrimidine dimers (CPDs) or 8-oxoguanine in irradiated nevi and unirradiated control nevi from each participant. Differences will be measured in percentage points ranging from 0 to 100 with no transformation prior to analysis.	Up to 1 year
Difference in the number of sunburn cells per high power field in irradiated and unirradiated control nevi	Will use immunohistochemical analysis of biopsies to examine the difference between the number of apoptotic keratinocytes (sunburn cells) in irradiated nevi and unirradiated control nevi from each participant. Differences will be measured in percentage points ranging from 0 to 100 with no transformation prior to analysis.	Up to 1 year
Percent of the area of the epidermis that is positive for Langerhans cells	Will use immunohistochemical analysis of biopsies to examine the difference between the area of the epidermis positive for Cd1a in irradiated and unirradiated control nevi. Differences will be measured in percentage points ranging from 0 to 100 with no transformation prior to analysis.	Up to 1 year

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Pamela Cassidy, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): November 21, 2021
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: STUDY00022830 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-06210 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No