UVA-1 Therapy for Sclerosing Skin Diseases

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Pregnancy, UV light therapy, others

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

Compensation: Varies

Number of Visits: 30

Duration: Approximately 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well UVA-1 therapy (a type of light therapy) alleviates symptoms in people with specific skin conditions. It focuses on individuals with systemic scleroderma, morphea, or sclerodermatous Graft-Versus-Host Disease, which cause skin hardening. Participants will undergo 30 UVA-1 treatment sessions and report on their skin's condition before and after. The trial seeks individuals diagnosed with one of these skin conditions who can commit to 30 treatment sessions over approximately three months. As an unphased trial, this study offers participants the chance to contribute to understanding how UVA-1 therapy can improve skin conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that UVA-1 therapy is safe for treating sclerosing skin diseases?

Research has shown that UVA-1 therapy is generally safe for treating skin conditions like systemic scleroderma and morphea. In one study, all patients who received high doses of UVA-1 therapy noticed softer skin, and some even experienced complete resolution of their skin issues. Another study found that UVA-1 therapy was well-tolerated, with 83.3% to 100% of patients improving, depending on the dose.

While most patients experience positive results, these studies did not detail specific side effects. However, the regular use and reported improvements suggest that serious side effects are rare. If considered for other conditions, this information provides reassurance about UVA-1 therapy's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about UVA-1 Therapy for sclerosing skin diseases because it offers a unique approach compared to traditional treatments like corticosteroids and immunosuppressive drugs. Unlike these standard treatments, which work by broadly dampening the immune system, UVA-1 Therapy uses a specific range of ultraviolet light to target the skin directly and potentially reduce fibrosis. This method not only provides a non-invasive alternative but may also minimize systemic side effects, making it a promising option for patients seeking relief with fewer risks.

What evidence suggests that UVA-1 therapy might be an effective treatment for sclerosing skin diseases?

Research has shown that UVA-1 therapy effectively treats several skin conditions, including scleroderma. In one study, all patients using high-dose UVA-1 therapy reported softer skin, with some experiencing complete clearing of their skin issues. Another study found improved skin flexibility and movement in patients. This therapy penetrates deeply into the skin, reducing the thickness and hardness of affected areas. Overall, UVA-1 therapy appears promising for improving symptoms in skin diseases that cause hardening. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher B. Hansen, M.D.

Principal Investigator

University of Utah MidValley Dermatology

Are You a Good Fit for This Trial?

This trial is for adults over 18 with sclerosing skin diseases like systemic scleroderma, morphea, or Graft-Versus-Host Disease affecting the skin. Participants must be able to complete 30 UVA-1 therapy sessions within 100 days and provide consent. Pregnant individuals, those intolerant to UV light, or who have used UV therapy/tanning beds in the last month cannot join.

Inclusion Criteria

I can attend 30 treatments within 100 days.

Must be able to understand and provide written informed consent

I have been diagnosed with systemic scleroderma or similar skin hardening conditions.

Exclusion Criteria

I cannot attend all required study visits.

Current pregnancy or planned pregnancy during the study period

I have not had UV light therapy in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 30 sessions of UVA-1 phototherapy to treat sclerosing skin diseases

Approximately 14 weeks

30 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

• UVA-1 Therapy

Trial Overview The study aims to measure patient-reported improvements after undergoing 30 sessions of UVA-1 phototherapy for treating sclerosing skin conditions. It's a prospective trial where patients self-report outcomes and undergo clinical assessments before and after treatment.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36052749/

Efficacy of ultraviolet A1 phototherapy for inflammatory, ... Conclusions: UVA1 phototherapy is an effective treatment for a variety of skin conditions. In most patients, at least eight treatments of a medium-high dosage ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04922736

Patient Reported Outcomes with UVA-1 Therapy for ... The purpose of this study is to assess the degree of improvement seen patient reported outcomes after 30 sessions of UVA-1 therapy in treating systemic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5622270/

UVA1 a promising approach for scleroderma - PMC All patients undergoing high-dose UVA1 therapy reported softening of sclerotic plaques, and complete clearance was observed in 4 of 10 patients. Whereas, 5 of 7 ...

4. mdpi.com mdpi.com/2075-1729/13/3/669

Efficacy and Satisfaction of Low Doses UVA1 Phototherapy UVA1 therapy has also been demonstrated to improve the symptomatology of cutaneous mastocytosis [39]. Stege et al. [40] reported improvement of symptoms in 4/4 ...

5. cureus.com cureus.com/articles/354292-effect-of-uv-a1-phototherapy-treatment-on-scleroderma-a-systematic-review.pdf

Effect of UV-A1 Phototherapy Treatment on Scleroderma Overall, patients who received UV-A1 phototherapy saw beneficial effects, including improvements in skin elasticity, mobility of extremities,.

6. jwatch.org jwatch.org/na38337/2015/07/07/uva1-phototherapy-safe-and-effective-sclerosing-skin

UVA1 Phototherapy Is Safe and Effective for Sclerosing ... Respectively, 20%, 83.3%, and 100% of systemic scleroderma patients treated with low-, medium- and high-dose UVA1 responded. A similar result ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S019096229870533X

Low-dose UVA1 phototherapy for treatment of localized ... According to clinical and ultrasound criteria, more than 80% of the sclerotic lesions disappeared or markedly improved during UVA1irradiation in 18 of the 20 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9969991/

Morphea: The 2023 update - PMC - PubMed Central Morphea, also known as localized scleroderma, is a rare inflammatory connective tissue disorder occurring primarily in children aged 2–14 years ...