Other Skin Changes Due to Chronic Exposure to Nonionizing RadiationNCT06177106
SUV PDL1/PD1 in Sun Damaged & Sun Protected Human Skin of Participants
A study testing Solar Simulated Light in people with Other Skin Changes Due to Chronic Exposure to Nonionizing Radiation, run by University of Arizona at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other Skin Changes Due to Chronic Exposure to Nonionizing Radiation
- What is being tested?
- Solar Simulated Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals 40 years of age or older. Note: When the two groups are paired, participants will be balanced within 5 years of age. Ex. From 2.5 years younger or 2.5 years older.
- Individuals with moderate or severe photodamage of the skin on the forearms and Fitzpatrick skin type II or III (21 CFR 352.72).
- Individuals with a history of two or more cSCCs within the past 5 years (maximum of 23 enrolled) or individuals with no history of cSCC (maximum of 23 enrolled)
- Females of childbearing potential will need to undergo a pregnancy test at the enrollment visit, after administration of the ICF (informed consent form) and before exposure to solar simulated light (SSL) Premenopausal female subjects must use an effective method of birth control (such as oral contraceptives, consistent use of barrier contraceptives, IUD (intrauterine device), or other proven method of birth control) during study participation. For the purposes of this study, a woman will be considered postmenopausal if any of the following criteria are met: (1) she has had prior bilateral oophorectomy; (2) she is over the age of 60 years; or (3) she is under the age of 60 years and has not had a menstrual period in 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression.
- Individuals who are willing to limit sun exposure to the body during the study period and who agree to wear protective clothing when they are outdoors.
- Individuals who have the ability to understand and willingness to sign an informed consent before initiation of study procedures, after the nature of the study is explained to them and they have had the opportunity to ask any questions.
Who cannot join
- Individuals with any inflammation or irritation of the skin at the test areas, or any skin conditions felt by the study healthcare provider to contraindicate enrollment. This includes, but is not limited to, psoriasis or atopic dermatitis within the test areas. (Test area is defined as the 6 mm areas of skin that is exposed to SSL and will be biopsied.)
- Individuals with a history of untreated skin cancer or melanocytic lesions in the test areas are ineligible. History of such conditions at a body site other than the test areas is not exclusionary if in the opinion of the study healthcare provider it will not pose a risk to the subject.
- Individuals who have had invasive cancer, chemotherapy or radiation therapy within five years of study enrollment
- Individuals who are immunosuppressed by virtue of medication or disease. This includes AIDS patients, subjects taking oral steroids, and subjects on immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or biologic therapy), as determined by the examining study healthcare provider
- Individuals with serious intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or other situations that in the opinion of the examining study physician would limit compliance or interfere with the study regimen.
- Individuals who have used photosensitizing drugs within 30 days of enrollment, or who will be using a photosensitizing drug during the time of the study, will not be eligible.
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- Individuals who have used any topical medication other than emollients or sunscreen/sunblock on the test area within 30 days prior to study enrollment. If a study participant requires topical medication to the test area during the study, they will be withdrawn from the study.
- Individuals who have used retinoids, steroids, 5-fluorouracil, Levulan, Vaniqua (eflornithine), Solaraze, or Imiquimod (Aldara®) anywhere on the body within 30 days prior to study enrollment. Subjects may be reconsidered for eligibility 30 days after the last topical treatment with such medications.
- Individuals must not take mega-doses of vitamins. Mega-doses are defined as more than 5 capsules of standard multivitamins daily or more than the Tolerable Upper Intake Levels of Vitamins, as defined by the Institute of Medicine, National Academy of Sciences. Such vitamin therapy must be discontinued at least 30 days prior to study entry.
- Individuals with a history of deliberate natural or artificial sun exposure (tanning) within 30 days of study enrollment are not eligible.
- Individuals with Fitzpatrick skin type I are ineligible, as the proposed SSL dose could result in a burn of greater than mild severity.
- Individuals with Fitzpatrick skin type IV, V or VI are ineligible, as they are unlikely to exhibit a salient response in the proposed design.
- Individuals currently enrolled in or who plan to enroll in another clinical trial. There must be a 30-day period between completing a previous study and enrolling in this study.
- Individuals with a known allergy to lidocaine are not eligible.
- Females who are pregnant or nursing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85719
Stephanie Soto, stephm1@arizona.edu
UACC IIT, UACC-IIT@uacc.arizona.edu
About this study
Official title: An Assessment of Acute Solar UV-induced PD-L1/PD1 Expression in Sun Damaged & Sun Protected Human Skin of Participants With and Without History of SCC
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.
- Being tested
- Solar Simulated Light
- Keywords
- Sun Damaged Skin, Squamous Cell Skin Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solar Simulated LightOther
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 group | Role | What they receive |
|---|---|---|
| Cohort A - history of > 2 Cutaneous squamous cell carcinoma (cSCC) | Other | 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. Receives: Other: Solar Simulated Light |
| Cohort B - no history of cSCC | Other | 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. Receives: Other: Solar Simulated Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess PD-L1 protein expression levels in the epidermal keratinocytes of subjects with and without a history of cutaneous squamous cell skin cancer.
The primary objective will be the relative increase in PD-L1 protein expression levels in the epidermal keratinocytes of subjects in two risk cohorts (Cohort A (history of > 2 cSCC) and Cohort B (no history of cSCC)) after acute solar simulated light treatment compared to unexposed skin within the same subject. Proteomic evaluation will be performed by reverse phase protein microarray and confirmatory IHC (immunohistochemistry) stain.
Measured: Changes from baseline (pre-SSL exposure) to post-SSL exposure (at 24 hour post-exposure).
Secondary outcomes (3)
Evaluation of CD70/CD27 protein expression analysis
Reverse phase protein microarray will be implemented to evaluate changes in CD70/CD27 protein expression and immunohistochemistry assays will analyze changes in these signaling pathways over time.
Measured: Changes from baseline (pre-SSL exposure) to post-SSL exposure (at 24 hour post-exposure).
Spatial genomic assessment through whole transcriptomic analysis
Nanostring DSP (Digital Spatial Profiling). Whole transcriptomic analysis will assess these markers as well as query signaling pathways which may be differentially affected by UV in each group. The research team will perform NanoString spatial whole transcriptomic analysis on SD (sun damaged) skin samples in the 20 participants from each cohort by evaluating both pre- and post- SSL exposure, resulting in 2 matched pairs per study subject. The research team will also use DermTech RNA-seq for skin sampling and gene expression analysis on a subset of sun damaged skin samples.
Measured: Changes from baseline (pre-SSL exposure) to post-SSL exposure (at 24 hour post-exposure).
High dimensional data analysis
The objective is to integrate the proteomic and genomic data to evaluate possible synergistic relationship between them in describing the risk of cSCC based on PD-L1/PD1 and other co-expressed genes/protein expression.
Measured: Changes from baseline (pre-SSL exposure) to post-SSL exposure (at 24 hour post-exposure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start26 Dec 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Skin Changes Due to Chronic Exposure to Nonionizing RadiationStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clara Curiel-Lewandrowski, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177106
- Sponsor's protocol ID
- STUDY00003323
- Other IDs
- P01CA027502
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Acute Solar UV-induced PD-L1/PD1 Expression in Sun Damaged & Sun Protected Human Skin of Participants With and Without History of SCC
- ClinicalTrials.gov ID
- NCT06177106
- Acronym / sponsor ID
- STUDY00003323
- Keywords
- Sun Damaged Skin, Squamous Cell Skin Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A - history of > 2 Cutaneous squamous cell carcinoma (cSCC) | Other | Other: Solar Simulated LightParticipants 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. |
| Cohort B - no history of cSCC | Other | Other: Solar Simulated LightParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy individuals 40 years of age or older. Note: When the two groups are paired, participants will be balanced within 5 years of age. Ex. From 2.5 years younger or 2.5 years older.
- Individuals with moderate or severe photodamage of the skin on the forearms and Fitzpatrick skin type II or III (21 CFR 352.72).
- Individuals with a history of two or more cSCCs within the past 5 years (maximum of 23 enrolled) or individuals with no history of cSCC (maximum of 23 enrolled)
- Females of childbearing potential will need to undergo a pregnancy test at the enrollment visit, after administration of the ICF (informed consent form) and before exposure to solar simulated light (SSL) Premenopausal female subjects must use an effective method of birth control (such as oral contraceptives, consistent use of barrier contraceptives, IUD (intrauterine device), or other proven method of birth control) during study participation. For the purposes of this study, a woman will be considered postmenopausal if any of the following criteria are met: (1) she has had prior bilateral oophorectomy; (2) she is over the age of 60 years; or (3) she is under the age of 60 years and has not had a menstrual period in 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression.
- Individuals who are willing to limit sun exposure to the body during the study period and who agree to wear protective clothing when they are outdoors.
Key exclusion criteria (15 listed)
- Individuals with any inflammation or irritation of the skin at the test areas, or any skin conditions felt by the study healthcare provider to contraindicate enrollment. This includes, but is not limited to, psoriasis or atopic dermatitis within the test areas. (Test area is defined as the 6 mm areas of skin that is exposed to SSL and will be biopsied.)
- Individuals with a history of untreated skin cancer or melanocytic lesions in the test areas are ineligible. History of such conditions at a body site other than the test areas is not exclusionary if in the opinion of the study healthcare provider it will not pose a risk to the subject.
- Individuals who have had invasive cancer, chemotherapy or radiation therapy within five years of study enrollment
- Individuals who are immunosuppressed by virtue of medication or disease. This includes AIDS patients, subjects taking oral steroids, and subjects on immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or biologic therapy), as determined by the examining study healthcare provider
- Individuals with serious intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or other situations that in the opinion of the examining study physician would limit compliance or interfere with the study regimen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solar Simulated LightAcute 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. | Other | Cohort A - history of > 2 Cutaneous squamous cell carcinoma (cSCC), Cohort B - no history of cSCC |
Primary outcome
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).
The primary objective will be the relative increase in PD-L1 protein expression levels in the epidermal keratinocytes of subjects in two risk cohorts (Cohort A (history of > 2 cSCC) and Cohort B (no history of cSCC)) after acute solar simulated light treatment compared to unexposed skin within the same subject. Proteomic evaluation will be performed by reverse phase protein microarray and confirmatory IHC (immunohistochemistry) stain.
3 secondary outcomes
Evaluation of CD70/CD27 protein expression analysis
Time frame: Changes from baseline (pre-SSL exposure) to post-SSL exposure (at 24 hour post-exposure).
Spatial genomic assessment through whole transcriptomic analysis
Time frame: Changes from baseline (pre-SSL exposure) to post-SSL exposure (at 24 hour post-exposure).
High dimensional data analysis
Time frame: Changes from baseline (pre-SSL exposure) to post-SSL exposure (at 24 hour post-exposure).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clara Curiel-Lewandrowski, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solar Simulated Light in people with Other Skin Changes Due to Chronic Exposure to Nonionizing Radiation, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Soto (520-694-2020, stephm1@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.