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Simulated Sunlight for Radiodermatitis

N/A
Recruiting
Led By Clara Curiel-Lewandrowski, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals with moderate or severe photodamage of the skin on the forearms and Fitzpatrick skin type II or III
Individuals with a history of two or more cSCCs within the past 5 years or individuals with no history of cSCC
Must not have
Immunosuppressed individuals by virtue of medication or disease
Individuals with untreated skin cancer or melanocytic lesions in the test areas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from baseline (pre-ssl exposure) to post-ssl exposure (at 24 hour post-exposure).
Awards & highlights

Summary

This trial is studying how people's skin changes when exposed to simulated sunlight. The researchers want to compare the skin of people who have had skin cancer to those who haven't, even if they have similar

Who is the study for?
This study is for people who have had skin cancer and those who haven't, but both groups should have similar skin types and sun exposure histories. Participants will undergo simulated sunlight exposure to their skin and must be willing to have small skin samples taken.
What is being tested?
The trial aims to understand how proteins and genes in the skin respond to simulated sunlight. It involves exposing small areas of participants' skin to artificial light that mimics the sun's rays, followed by taking biopsies for analysis.
What are the potential side effects?
Participants may experience mild to moderate sunburn-like effects or tanned spots where the simulated sunlight touches their skin. There might also be brief discomfort from injections of local anesthetic before biopsy procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate to severe sun damage on my forearms and have light to olive skin.
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I have had two or more skin cancers in the past 5 years or none at all.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am immunosuppressed due to medication or a condition.
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I have untreated skin cancer or suspicious moles in the areas to be tested.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from baseline (pre-ssl exposure) to post-ssl exposure (at 24 hour post-exposure).
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline (pre-ssl exposure) to post-ssl exposure (at 24 hour post-exposure). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess PD-L1 protein expression levels in the epidermal keratinocytes of subjects with and without a history of cutaneous squamous cell skin cancer.
Secondary study objectives
Evaluation of CD70/CD27 protein expression analysis
High dimensional data analysis
Spatial genomic assessment through whole transcriptomic analysis

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B - no history of cSCCExperimental Treatment1 Intervention
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.
Group II: Cohort A - history of > 2 Cutaneous squamous cell carcinoma (cSCC)Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
525 Previous Clinical Trials
155,202 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,954 Total Patients Enrolled
11 Trials studying Radiodermatitis
1,474 Patients Enrolled for Radiodermatitis
Clara Curiel-Lewandrowski, MDPrincipal InvestigatorUniversity of Arizona
~16 spots leftby Mar 2025
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