Simulated Sunlight for Radiodermatitis

Overseen By Stephanie Soto

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Steroids, Immunosuppressants, Retinoids, others

Disqualifiers: Psoriasis, Untreated cancer, Immunosuppressed, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how skin proteins and genes change when exposed to simulated sunlight (Solar Simulated Light), comparing individuals with a history of skin cancer to those without. Researchers aim to understand why some people develop skin cancer while others do not, despite having similar skin types and sun exposure histories. Participants will receive simulated sunlight on small skin areas and undergo skin biopsies (small samples taken for study). Individuals with noticeable sun damage on their forearms and either a history of squamous cell skin cancer or none at all might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on skin cancer prevention.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications and supplements before joining. You must not use photosensitizing drugs, certain topical medications, or take mega-doses of vitamins for at least 30 days before the study. If you need to use these during the study, you will be withdrawn.

What prior data suggests that simulated sunlight exposure is safe for skin?

Research shows that exposure to solar simulated light (SSL) can cause some skin reactions. Studies have found that direct exposure to UV light, such as SSL, can lead to sunburn, redness, and changes in skin cells. However, these effects are usually mild and temporary when exposure is carefully controlled and limited, as in many studies.

In trials where participants were exposed to SSL, some experienced mild sunburn or tanned spots. These are normal skin reactions and usually don't last long. More serious side effects, like skin damage or cancer, are generally linked to long-term exposure to UV light, not the short bursts used in research settings like this one.

Overall, while SSL can cause temporary skin changes, it is generally well-tolerated in controlled research environments. Participants might feel some discomfort, but it's usually minimal and short-lived. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using solar simulated light (SSL) for treating radiodermatitis because it offers a unique, non-invasive approach that mimics natural sunlight. Unlike traditional treatments, which often involve topical creams or medications, this method could harness the beneficial aspects of sunlight exposure to repair skin damage. The hope is that SSL can stimulate natural healing processes in the skin, potentially reducing symptoms more effectively and with fewer side effects than current options. This innovative approach could provide a new avenue for managing skin conditions related to radiation exposure, offering patients a more natural and gentle alternative.

What evidence suggests that solar simulated light is effective for studying radiodermatitis?

This trial will expose participants to solar simulated light (SSL), which mimics the sun's UV rays, to study its effects on skin proteins and genes. Participants in Cohort A have a history of more than two cutaneous squamous cell carcinomas (cSCC), while those in Cohort B have no history of cSCC. Research has shown that these UV rays can cause sunburn and inflammation. Studies have also found that UV radiation can increase certain fats in the skin that are important for the body's immune response. While this study aims to understand these changes, previous research has demonstrated that UV exposure can damage the skin and even lead to skin cancer. Understanding these effects is especially important for people who have had skin cancer before. ^{2 3 4 6 7}

Who Is on the Research Team?

Clara Curiel-Lewandrowski, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had two or more skin cancers in the past 5 years or none at all.

I am using birth control and will take a pregnancy test if I can have children.

I am willing to limit my time in the sun and wear protective clothing during the study.

Exclusion Criteria

Individuals taking mega-doses of vitamins

I am immunosuppressed due to medication or a condition.

Individuals with a history of deliberate natural or artificial sun exposure within 30 days of study enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are exposed to acute solar simulated light (SSL) and undergo skin biopsies to assess protein and gene expression changes

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Solar Simulated Light

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort B - no history of cSCC Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 10 male Wistar rats, treatment with LED light (660 nm) for 21 days after radiation exposure significantly improved skin regeneration, as indicated by increased dermal appendages and angiogenesis compared to the control group.

The LED treatment also showed a trend towards higher levels of interleukin-10 (IL-10), which is associated with anti-inflammatory responses, and a significant increase in matrix metalloproteinase-9 (MMP-9), suggesting enhanced tissue remodeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light-emitting diode stimulates radiodermatitis recovery. Camargo, CP., Carvalho, HA., Maluf, FC., et al.[2021]

Only 9% of the studies on radiodermatitis from breast cancer radiotherapy included patient-rated measures, highlighting a significant gap in understanding patient experiences.

Current assessment scales for radiodermatitis are mostly brief and focus on physical symptoms, with no established 'gold standard' for measuring patient-reported outcomes, indicating a need for more comprehensive research and scale development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of patient-rated measures of radiodermatitis in breast cancer radiotherapy. Schnur, JB., Love, B., Scheckner, BL., et al.[2022]

In a study of 200 breast cancer patients undergoing adjuvant radiotherapy, higher body mass index (BMI) and larger planning target volume (PTV) were identified as significant risk factors for developing acute radiodermatitis grade ≥2, with BMI >30 showing a notably high odds ratio of 9.31.

The study found that no cases of grade 3 radiodermatitis occurred, and the incidence of grade 2 radiodermatitis was lower than previously reported, suggesting that factors like patient BMI, skin type, and tumor histology are important considerations in managing radiodermatitis risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prognostic factors of acute radiodermatitis in breast cancer after adjuvant radiotherapy treated with RT3D or IMRT]. Thomas, A., Keller, A., Menoux, I., et al.[2022]

Photobiomodulation therapy (PBMT) was found to be associated with a higher incidence of grade 1 radiation dermatitis (RD) in breast cancer patients compared to the control group, indicating a potential risk when using this treatment.

Despite the increased risk of grade 1 RD, PBMT showed a promising ability to prevent more severe forms of RD (grade 2 and grade 3), particularly grade 3 RD, although the evidence for this is very low certainty, suggesting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of photobiomodulation therapy in radiation dermatitis: A systematic review and meta-analysis. Aguiar, BRL., Guerra, ENS., Normando, AGC., et al.[2021]

The study found that the sun protection factor (SPF) of an experimental sunscreen was equivalent when tested under both a xenon arc solar simulator and natural sunlight, indicating that the simulator can effectively mimic natural sunlight for SPF testing.

To achieve comparable SPF results, it was necessary to provide additional heat to the skin before exposure to the solar simulator, highlighting the importance of environmental control in testing conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The correlation of indoor solar simulator and natural sunlight: testing of a sunscreen preparation. Sayre, RM., Desrochers, DL., Marlowe, E., et al.[2013]

A study involving 70 breast cancer patients found that different topical agents used to prevent acute radiation dermatitis (ARD) had significantly different cosmetic properties, which can affect patient adherence to treatment.

Patients reported that the performance, absorption, and residue of these creams varied, suggesting that selecting topical agents with better cosmetic profiles could enhance treatment compliance and overall satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' view of the differences in topical creams for radiation dermatitis prevention. A pilot study of cosmetic properties. Sabater, S., Leon, R., Esteban, C., et al.[2022]

In a pilot study involving 33 patients undergoing high-dose radiation therapy (60 Gy or higher), photobiomodulation (PBM) therapy was found to be safe and feasible, with no significant side effects reported.

Only 39% of patients experienced severe radiodermatitis (grade 2b or higher), and just 9% had grade 3 toxicity, suggesting that PBM therapy may help reduce the severity of skin reactions compared to previous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of photobiomodulation therapy for the prevention of radiodermatitis: a single-institution pilot study. Park, JH., Byun, HJ., Lee, JH., et al.[2020]

A study of 93 psoriatic patients found that a daily exposure dose of 317.9 J/m² is effective for psoriasis healing, establishing it as the standard antipsoriatic dose (SAPD) for phototherapy.

The research suggests that heliotherapy, or sun exposure, can serve as an effective alternative to cabinet phototherapy for treating psoriasis, especially in southern/eastern Poland, where solar radiation during certain months can provide sufficient therapeutic doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of the antipsoriatic heliotherapy in Poland. Krzyścin, JW., Narbutt, J., Lesiak, A., et al.[2014]

Chronic actinic dermatitis (CAD) is a type of eczema triggered by ultraviolet radiation or visible light, primarily affecting older individuals, but it can also occur in younger people, as demonstrated by the case of a young pilot.

The pilot's CAD was exacerbated by exposure to visible light through his aircraft cockpit window, highlighting the importance of protecting against light exposure for individuals with atopic eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exacerbation of presumed chronic actinic dermatitis by cockpit visible light in an airline pilot with atopic eczema. Yones, SS., Palmer, RA., Hextall, JM., et al.[2005]

Current literature does not provide strong evidence to recommend specific topical or oral agents for preventing or managing radiation skin reactions, indicating a need for more research in this area.

Limited evidence suggests that calendula cream may help reduce the incidence of severe skin reactions (grade 2 and 3) in women undergoing breast cancer treatment, and early studies on barrier films or creams show potential for improving moist desquamation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based skin care management in radiation therapy. McQuestion, M.[2022]

A broad-spectrum daily-care product with low SPF (8) effectively prevents biological damage from repeated daily ultraviolet radiation (DUVR) exposure, which can lead to skin cancer and photoaging.

The level of protection offered by the daily-care product varies depending on the specific cellular and molecular markers assessed, highlighting the importance of consistent UV protection even from low-level sun exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A broad-spectrum sunscreen prevents cumulative damage from repeated exposure to sub-erythemal solar ultraviolet radiation representative of temperate latitudes. Seité, S., Christiaens, F., Bredoux, C., et al.[2010]

In a study involving 20 patients with various photodermatoses, exposure to infrared radiation was found to be necessary for the development of skin lesions in 85% of the participants.

When infrared radiation was blocked, 85% of patients did not develop any lesions, suggesting that infrared radiation plays a significant role in exacerbating skin conditions related to light exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water-Filtered Infrared Radiation Decreases the Generation of Photodermatoses Dependent on Ultraviolet and Visible Radiation. de Gálvez, MV., Aguilera, J., Sánchez-Roldán, C., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4531259/

Dermatopathology effects of simulated solar particle event ... Radiation-induced skin damage is often one of the first clinical signs of both acute and non-acute radiation injury where infection may occur, if not treated.

2. stacks.cdc.gov stacks.cdc.gov/view/cdc/196647

Simulated Solar UV Light (SSL) Induces Inflammation and ... The skin is continuously exposed to a variety of hazardous environmental insults, such as ultraviolet light, ozone, and ionizing radiation.

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

Current insights and future perspectives of ultraviolet ... Direct exposure of skin to sunlight or UV radiation can result in sunburn, inflammation, photo-immunosuppression, photoaging and even skin cancers.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7295106/

Topical treatment of radiation-induced dermatitis Approximately 95% of patients receiving radiotherapy (RT) will ultimately develop radiation-induced dermatitis (RID) during or after the course of treatment, ...

5. link.springer.com link.springer.com/article/10.1007/s43630-023-00375-8

The effects of exposure to solar radiation on human health Exposing the skin to solar-simulated UV radiation causes an increase in the production of immunomodulatory lipids such as platelet-activating ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/php.13850

Evaluation of human skin response to solar‐simulated ... Results showed that L-Carnosine provides effective prevention against solar radiation damages reducing ROS, AGEs and mitigating the modulation of the selected ...

7. nature.com nature.com/articles/s41598-018-33031-8

Solar simulated light exposure alters metabolization and ... Although positive in terms of immediate impact, this result may also suggest that parent PAH accumulate longer in irradiated skin. Indeed, only ...