SUV PDL1/PD1 in Sun Damaged & Sun Protected Human Skin of Participants

Conditions

• Other Skin Changes Due to Chronic Exposure to Nonionizing Radiation

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Solar Simulated Light — OTHER
  Acute SSL will be delivered to sun damaged skin at a rate of two-times the minimal erythema dose of each individual subject. Minimal erythema dose is defined as the smallest dose of energy necessary to produce confluent erythema with four distinct borders at 22-26 hours post-exposure.

Study Details

The purpose of this research study is to look at how the proteins and genes in people's skin change when they're exposed to simulated sunlight. The researchers want to see if there are differences between people who've had skin cancer and those who haven't despite having a similar type of skin and history of sun exposure. Since this study is designed to simulate sun exposure to small areas of skin, mild to moderate sunburn and tanned spots at the site of the simulated sunlight exposure is a risk. In addition to simulated sun exposure, patients will also have four 6 mm punch skin biopsies performed. Brief discomfort may be felt when the local painkiller (lidocaine) is injected prior to skin biopsies; however, it is usually minimal. Participation in the study involves 4 visits to the clinic over the course of 4 weeks. Each visit will take no longer than 90 minutes.

Key Dates

Start date

Dec 26, 2023

Status verified

Apr 2026

Primary completion

Mar 1, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

46 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Other: Cohort A - history of > 2 Cutaneous squamous cell carcinoma (cSCC)
  Participants who have a history of squamous cell skin cancer (n=23) will be exposed to acute solar simulated light (SSL). Participants must have sun damage on the forearm, based on a standardized clinical photodamage scale (Hu C, Curiel-Lewandrowski C. Archives of Dermatology, 2011; 147(1):31-36). Each subject will act as his/her own control to minimize inter-subject variability. Subjects from each cohort will be matched based on age and gender.
• Other: Cohort B - no history of cSCC
  Participants without a history of squamous cell skin cancer (n=23) will be exposed to acute solar simulated light (SSL). Participants must have sun damage on the forearm, based on a standardized clinical photodamage scale (Hu C, Curiel-Lewandrowski C. Archives of Dermatology, 2011; 147(1):31-36). Each subject will act as his/her own control to minimize inter-subject variability.

Primary Outcome Measure

To assess PD-L1 protein expression levels in the epidermal keratinocytes of subjects with and without a history of cutaneous squamous cell skin cancer. [ Time Frame: Changes from baseline (pre-SSL exposure) to post-SSL exposure (at 24 hour post-exposure). ]

Central Contacts

• Stephanie Soto
  520-694-2020
  [email protected]

Locations (1)

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