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

Trial Summary

What is the purpose of this trial?

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.

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 If you need to use these during the study, you will be withdrawn.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 data supports the effectiveness of the treatment Solar Simulated Light for radiodermatitis?

Research on similar treatments, like photobiomodulation therapy (PBMT), shows they can help prevent and treat radiation dermatitis, suggesting that Solar Simulated Light might also be effective. ^{1 2 3 4 5}

Is simulated sunlight safe for treating radiodermatitis?

Research on photobiomodulation (a type of light therapy) for radiodermatitis shows it is generally safe, with no significant side effects reported in a pilot study. This suggests that similar light-based treatments, like simulated sunlight, might also be safe for humans. ^{1 6 7 8 9}

How does the simulated sunlight treatment for radiodermatitis differ from other treatments?

Simulated sunlight treatment for radiodermatitis is unique because it uses a solar simulator to mimic natural sunlight, potentially offering a controlled and consistent exposure compared to natural sunlight. This approach may help in managing radiodermatitis by providing a standardized light exposure, which is not typically available with other treatments. ^{1 7 10 11 12}

Research Team

Clara Curiel-Lewandrowski, MD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Light-emitting diode stimulates radiodermatitis recovery. [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Prognostic factors of acute radiodermatitis in breast cancer after adjuvant radiotherapy treated with RT3D or IMRT]. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A systematic review of patient-rated measures of radiodermatitis in breast cancer radiotherapy. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of photobiomodulation therapy in radiation dermatitis: A systematic review and meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

The correlation of indoor solar simulator and natural sunlight: testing of a sunscreen preparation. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility of photobiomodulation therapy for the prevention of radiodermatitis: a single-institution pilot study. [2020]

9. Poland pubmed.ncbi.nlm.nih.gov

Patients' view of the differences in topical creams for radiation dermatitis prevention. A pilot study of cosmetic properties. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Perspectives of the antipsoriatic heliotherapy in Poland. [2014]

11. England pubmed.ncbi.nlm.nih.gov

Exacerbation of presumed chronic actinic dermatitis by cockpit visible light in an airline pilot with atopic eczema. [2005]

12. United States pubmed.ncbi.nlm.nih.gov

Water-Filtered Infrared Radiation Decreases the Generation of Photodermatoses Dependent on Ultraviolet and Visible Radiation. [2020]