Clinical trial NCT05027009: Effects of Simulated Solar Radiation on Human Skin in Preventing Skin Cancer
Official title: Effects of Simulated Solar Radiation on Human Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2021-08-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of pixels positive for p53 by immunohistochemical analysis
timeFrame: Up to 1 year
Secondary outcomes:
measure: Deoxyribonucleic acid (DNA) damage
timeFrame: Up to 1 year
measure: Difference in the number of sunburn cells per high power field in irradiated and unirradiated control nevi
timeFrame: Up to 1 year
measure: Percent of the area of the epidermis that is positive for Langerhans cells
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Pamela Cassidy
role: PRINCIPAL_INVESTIGATOR
References: