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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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 scleroderma, morphea, and sclerodermatous Graft-Versus-Host Disease. While patients have verbally reported improvement of their sclerosing skin disease with UVA-1, patient reported outcomes have not been rigorously studied. In sclerosing skin diseases where clinical change is difficult to measure, patient reported outcomes may offer a better way to study the impact of treatments like UVA-1. This will be a non-blinded, non-randomized prospective trial using UVA-1 phototherapy in patients with established sclerosing skin disease. Patients will report the severity of their condition using multiple patient reported outcomes and will also be analyzed using multiple clinical investigator assessments at the beginning and end of 30 treatment sessions.

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 data supports the effectiveness of the treatment UVA-1 Therapy for sclerosing skin diseases?

Research shows that UVA-1 therapy is effective for treating sclerotic skin diseases, including localized scleroderma and systemic sclerosis, with improvements in skin hardness and lesions. Studies have demonstrated significant skin improvement in patients, indicating its effectiveness for these conditions. ^{1 2 3 4 5}

Is UVA-1 therapy safe for humans?

UVA-1 therapy is generally considered safe with minimal short-term side effects, but the long-term risks, such as skin cancer, are not well known. ^{1 6 7 8 9}

How is UVA-1 therapy different from other treatments for sclerosing skin diseases?

UVA-1 therapy is unique because it uses a specific range of ultraviolet light (340-400 nm) to treat sclerosing skin diseases, which can help reduce skin hardening by affecting collagen deposition. Unlike some other treatments, it is non-invasive and has been shown to be effective for conditions that are often resistant to standard therapies. ^{1 2 7 9 10}

Research Team

Christopher B. Hansen, M.D.

Principal Investigator

University of Utah MidValley Dermatology

Eligibility Criteria

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

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

Treatment Details

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+

References

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

Ultraviolet A phototherapy for sclerotic skin diseases: a systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Period of remission after treatment with UVA-1 in sclerodermic skin diseases. [2008]

3. England pubmed.ncbi.nlm.nih.gov

Low-dose UVA1 phototherapy for proximal and acral scleroderma in systemic sclerosis. [2009]

4. England pubmed.ncbi.nlm.nih.gov

Phototherapy and photochemotherapy of sclerosing skin diseases. [2005]

5. England pubmed.ncbi.nlm.nih.gov

Ultraviolet A1 phototherapy beyond morphea: experience in 83 patients. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Ultraviolet A1 phototherapy: a British Photodermatology Group workshop report. [2016]

7. Australia pubmed.ncbi.nlm.nih.gov

A retrospective review of UVA1 treatment: An Australian experience from a single centre. [2021]

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

Treatment regimens, protocols, dosage, and indications for UVA1 phototherapy: facts and controversies. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Low-dose UVA₁ phototherapy for scleroderma: what benefit can we expect? [2012]

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

Effect of increased pigmentation on the antifibrotic response of human skin to UV-A1 phototherapy. [2021]