Ultraviolet B Radiation for Skin Cancer

Overseen By Regulatory Specialist

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Jeffrey B. Travers, MD, PhD

Must not be taking: Photosensitizing, Hormonal agents

Disqualifiers: Photosensitivity, Diabetes, Skin cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the skin reacts to artificial sunlight, specifically ultraviolet B (UVB) radiation, at different times of the day. Researchers aim to determine if night shift workers' skin responds differently compared to day shift workers. This could enhance understanding of how work schedules affect skin health and potentially inform skin cancer prevention strategies. Suitable participants are those with fair skin who have worked primarily night or day shifts in the last three months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on skin health and work schedules.

Will I have to stop taking my current medications?

If you are currently taking photosensitizing medications or hormonal agents like birth control pills, you will need to stop taking them to participate in this trial.

What prior data suggests that ultraviolet B radiation is safe for skin exposure?

Research has shown that ultraviolet B (UVB) rays can be harmful. Studies have found that excessive UV exposure can cause skin cancer, the most common cancer in the U.S. UVB rays, in particular, greatly increase this risk. They can also lead to skin damage, such as wrinkles and loss of skin firmness over time. However, the risk depends on the amount and duration of exposure.

In this trial, researchers use UVB radiation on skin samples in the lab, not directly on participants, which may reduce personal exposure risks. Still, it's important to consider these known effects of UVB when evaluating safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultraviolet B (UVB) radiation for skin cancer because it offers a novel approach by directly targeting cancer cells with artificial sunlight. Unlike traditional treatments like surgery, chemotherapy, or topical medications, which can be invasive or systemic, UVB radiation is a controlled, localized exposure, potentially reducing side effects. This method could provide an alternative for people who work night shifts, whose skin may react differently to UVB exposure compared to day workers. By understanding these differences, researchers hope to tailor treatments more effectively, making skin cancer therapy more precise and personalized.

What evidence suggests that ultraviolet B radiation is effective for skin cancer?

Research has shown that ultraviolet B (UVB) rays are closely linked to skin cancer. Many studies have found that exposure to UVB can cause various types of skin cancer, including non-melanoma and melanoma. Excessive UV light can damage skin cells, leading to changes that might result in cancer. Although UVB is sometimes used in medical treatments, it carries significant risks, such as thinning of the skin, changes in skin color, and an increased chance of developing cancer. This trial will compare how skin responds to UVB exposure under different work schedules. Participants in the "Night Shift Work Schedule" arm and the "Day Shift Work Schedule" arm will have their skin biopsies exposed to artificial sunlight (UVB) in the laboratory. Understanding these responses is important for managing the associated risks. ^{5 6 7 8 9}

Who Is on the Research Team?

Jeffrey B Travers, MD, PhD

Principal Investigator

Wright State University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 with fair skin who work night shifts or a mix of day and night but mostly at night. They should be able to document their work schedule for the past three months. It's not open to those on hormonal treatments, allergic to lidocaine, pregnant/nursing women, people with serious health issues, abnormal scarring, skin infections/cancers, photosensitivity issues, sleep disorders like apnea/insomnia or diabetes.

Inclusion Criteria

I am either male or female.

I understand the procedures and risks involved.

You have very light skin (Fitzpatrick types I and II).

Exclusion Criteria

Known allergy to lidocaine local anesthetic

You have a history of unusual scarring.

I have a history of sleep disorders like sleep apnea or insomnia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy Collection

Skin biopsies are obtained from participants for laboratory analysis

1 day

1 visit (in-person)

Laboratory Analysis

Skin biopsies are exposed to UVB radiation and analyzed for DNA repair activity

1 hour

Follow-up

Participants are monitored for any adverse reactions post-biopsy and UVB exposure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• No Ultraviolet B Radiation
• Ultraviolet B Radiation

Trial Overview The study aims to understand how the skin of night shift workers reacts to artificial sunlight (UVB radiation) compared to day workers by exposing their biopsied skin samples in a lab setting. The response of the skin cells will help determine if working hours affect DNA repair activity related to potential skin cancer risk.

How Is the Trial Designed?

Group I: Night Shift Work Schedule Experimental Treatment 2 Interventions

Night shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.

Group II: Day Shift Work Schedule Experimental Treatment 2 Interventions

Day shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.

Who Is Running the Clinical Trial?

Jeffrey B. Travers, MD, PhD

Lead Sponsor

Trials

5

Recruited

160+

Wright State University

Lead Sponsor

Trials

47

Recruited

55,300+

Published Research Related to This Trial

UVB radiation is a well-established carcinogen that causes direct DNA damage leading to gene mutations, contributing significantly to skin cancer risk.

UVA radiation, while less carcinogenic than UVB, is more abundant in sunlight and can still promote cancer by generating reactive oxygen species that damage DNA and other cellular components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photocarcinogenesis: UVA vs UVB. de Gruijl, FR.[2022]

Ultraviolet (UV) radiation has several harmful effects on the skin, including causing sunburn, increasing the risk of skin cancers like basal and squamous cell carcinomas, and malignant melanomas.

Despite its harmful effects, sunlight also has beneficial roles, such as promoting the synthesis of vitamin D3 and positively influencing mental health through visible light exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biological effects of solar radiations]. Cesarini, JP., Binet, O.[2013]

In a study involving 12 healthy individuals, exposure to repetitive low doses of UVA1 and visible light resulted in increased expression of p53, indicating potential DNA damage in skin cells.

UVA1 exposure specifically led to increased cell proliferation markers (Ki67 and cyclin A), suggesting that even low doses of UVA1 can have significant biological effects on skin, similar to those caused by more harmful UV radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on human skin of repetitive ultraviolet-A1 (UVA1) irradiation and visible light. Edström, DW., Porwit, A., Ros, AM.[2019]

UVB irradiation of keratinocytes leads to significant changes in gene expression, with 57 genes upregulated and 27 downregulated, indicating a complex response to UVB exposure.

Notably, the downregulation of thrombospondin-1 (TSP-1), an angiogenesis inhibitor, and the upregulation of platelet-derived endothelial cell growth factor (PD-ECGF), an angiogenesis activator, suggest that UVB may promote neovascularization and contribute to the development of skin cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microarray analysis of UVB-regulated genes in keratinocytes: downregulation of angiogenesis inhibitor thrombospondin-1. Howell, BG., Wang, B., Freed, I., et al.[2006]

UVB irradiation significantly induces the expression of vascular endothelial growth factor (VEGF) in both human and mouse skin, suggesting a key role for VEGF in skin responses to UV exposure.

In a mouse model, repetitive UVB exposure led to increased blood vessel formation, which could be partially blocked by neutralizing VEGF antibodies, confirming VEGF's role in the angiogenic response to UVB irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular endothelial growth factor causally contributes to the angiogenic response upon ultraviolet B irradiation in vivo. Blaudschun, R., Sunderkötter, C., Brenneisen, P., et al.[2022]

Approximately 80.5% of basal cell carcinomas (BCCs) and 83.0% of squamous cell carcinomas (SCCs) in Canada are linked to ultraviolet radiation (UVR), highlighting the significant role of UV exposure in these skin cancers.

Modifiable behaviors such as adult sunburn and sunbathing contribute to a substantial portion of these cancers, with 46.2% of BCCs and 17.3% of SCCs attributable to such behaviors, indicating that prevention strategies could effectively reduce the incidence of non-melanoma skin cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current burden of non-melanoma skin cancer attributable to ultraviolet radiation and related risk behaviours in Canada. O'Sullivan, DE., Brenner, DR., Villeneuve, PJ., et al.[2021]

In a study of 1380 adults undergoing PUVA therapy, high exposure to UVB treatments (300 or more) was linked to a modest increase in the risk of developing squamous cell carcinoma (SCC) and basal cell carcinoma (BCC).

Despite this increased risk, UVB therapy is still considered a relatively low-risk treatment for psoriasis compared to PUVA, especially for patients with fewer than 100 PUVA treatments, where the risk of skin cancer was notably higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High levels of ultraviolet B exposure increase the risk of non-melanoma skin cancer in psoralen and ultraviolet A-treated patients. Lim, JL., Stern, RS.[2022]

In a study of 92 psoriatic patients treated with either PUVA (45%) or nb-UVB (55%) therapy over an average of 7.1 years, a total of 14 skin tumors were found in the nb-UVB group, including two melanomas, indicating a potential risk for skin cancer with this treatment.

The PUVA group had a lower incidence of skin tumors (4.7%), but still showed cases of melanoma and non-melanoma skin cancers, suggesting that both therapies carry risks and necessitate careful monitoring for skin cancer in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melanoma and non-melanoma skin cancer in psoriatic patients treated with high-dose phototherapy. Maiorino, A., De Simone, C., Perino, F., et al.[2018]

Sunlight, particularly UVB and UVA radiation, can cause skin cancer by damaging DNA and suppressing the immune system, leading to conditions like squamous cell carcinoma and melanoma.

Photolyase can effectively repair UVB-induced DNA damage, preventing immunosuppressive effects and skin damage, highlighting its potential as a protective treatment against UV radiation effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photocarcinogenesis]. Krutmann, J.[2008]

In a study of 4665 patients receiving narrow-band ultraviolet B (NB-UVB) treatment, no significant association was found between NB-UVB exposure and the development of skin cancers, including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), or melanoma.

A small increase in BCCs was observed among patients who also received psoralen-UVA (PUVA) treatment, suggesting that while NB-UVB alone appears safe, caution is warranted for those treated with both therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of skin cancers in 3867 patients treated with narrow-band ultraviolet B phototherapy. Hearn, RM., Kerr, AC., Rahim, KF., et al.[2022]

Ultraviolet radiation (UVR) is a major cause of skin cancer, with significant increases in incidence over recent decades, particularly affecting fair-skinned populations, as evidenced by approximately 100,000 new cases of cutaneous melanoma in Europe in 2012.

To reduce the risk of skin cancer, individuals should avoid excessive UVR exposure by seeking shade, wearing protective clothing, using sunscreen, and completely avoiding sunbeds, especially for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European Code against Cancer 4th Edition: Ultraviolet radiation and cancer. Greinert, R., de Vries, E., Erdmann, F., et al.[2018]

Vitamin D is essential for preventing falls and fractures in older adults, and its synthesis in the skin is triggered by UVB exposure.

However, relying on UV exposure for vitamin D synthesis is unsafe due to its carcinogenic effects, making oral supplementation the recommended method for preventing vitamin D deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vitamin D, ultraviolet rays and skin cancer]. Barysch, MJ., Feldmeyer, L., Bischoff-Ferrari, H., et al.[2010]

In a study of 375 patients treated with narrowband-ultraviolet B (NB-UVB) over an average follow-up of 6.9 years, 19 cases of non-melanoma skin cancers (NMSCs) were diagnosed, suggesting a potential carcinogenic risk associated with NB-UVB treatment.

The incidence of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) was notably higher in patients with psoriasis, indicating that those with pre-existing skin conditions may be at greater risk for developing skin cancers after NB-UVB therapy, although no cases of malignant melanoma were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous carcinogenic risk evaluation in 375 patients treated with narrowband-UVB phototherapy: A 15-year experience from our Institute. Raone, B., Patrizi, A., Gurioli, C., et al.[2018]

Solar UV-B radiation is linked to a reduced risk of various cancers, including breast, colon, ovarian, and prostate cancers, primarily through the production of vitamin D, based on extensive data analysis in the US and Europe.

The protective effects of UV-B radiation against cancer persist even when accounting for other risk factors like smoking and diet, with strong inverse correlations found for several cancers in multicountry studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ecologic studies of solar UV-B radiation and cancer mortality rates. Grant, WB.[2019]

Ultraviolet (UV) radiation can lead to skin cancer through various mechanisms, including DNA damage and immune system changes, raising concerns about the safety of phototherapy treatments.

While the risks of psoralen and UVA radiation (PUVA) are well-studied, there is limited safety data on other phototherapy types, such as broadband and narrowband UVB and UVA1, highlighting the need for ongoing skin cancer screening for patients who have received any form of phototherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distinguishing Myth from Fact: Photocarcinogenesis and Phototherapy. Thompson, KG., Kim, N.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9239121/

Risk of Skin Cancer with Phototherapy in Moderate-to- ... Three studies did report an increased risk of skin cancer with narrowband-UVB and broadband-UVB for FSP I-VI, with one study also not specifying ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0160412024001211

Current insights and future perspectives of ultraviolet ... Numerous epidemiological studies have demonstrated a strong correlation between UV radiation exposure and various types of skin cancers (Ahmed et al., 2020, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3709783/

UV Radiation and the Skin - PMC - PubMed Central Nonetheless, excessive exposure to UV carries profound health risks, including atrophy, pigmentary changes, wrinkling and malignancy. UV is epidemiologically ...

4. academic.oup.com academic.oup.com/bjd/article/193/4/718/8124470

Mutation burden of narrowband ultraviolet B phototherapy (NB ... Moreover, the data suggest that skin cancer surveillance starts earlier than 500 NB-UVB exposures in patients with MED ≤ 3 SED and average sun ...

5. who.int who.int/news-room/fact-sheets/detail/ultraviolet-radiation

Ultraviolet radiation Excessive exposure to UVR caused around 1.2 million new cases of non-melanoma skin cancers (SCC and BCC) and 325 000 melanomas of the skin, and ...

6. cancer.org cancer.org/cancer/risk-prevention/sun-and-uv/uv-radiation.html

Does UV Radiation Cause Cancer? Exposure to UV rays, whether from sunlight or tanning devices, is a risk factor for all types of skin cancer.

7. cdc.gov cdc.gov/radiation-health/data-research/facts-stats/ultraviolet-radiation.html

Facts About Ultraviolet Radiation Overexposure to UV radiation can lead to serious health issues, including cancer. Skin cancer is the most common cancer in the United States.

8. epa.gov epa.gov/radtown/ultraviolet-uv-radiation-and-sun-exposure

Ultraviolet (UV) Radiation and Sun Exposure UV light from tanning beds and the sun can cause skin cancer and wrinkling. Wear protective clothing. Wide brimmed hats offer good sun ...

9. hopkinsmedicine.org hopkinsmedicine.org/health/wellness-and-prevention/sun-safety

Sun Safety UVB rays cause a much greater risk of skin cancer than UVA. But UVA rays cause aging, wrinkling, and loss of elasticity. UVA also increases the damaging effects ...