UVA-1 Phototherapy for Scleroderma

Overseen By Adrianne Evans, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Photosensitizing medications

Disqualifiers: Pregnancy, UV therapy, others

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

Compensation: Varies

Number of Visits: 3

Duration: Approximately 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if UVA-1 phototherapy (a type of light therapy) can improve hand function in people with scleroderma, a condition that causes skin hardening and tightening. Researchers will treat one hand with UVA-1 light while covering the other hand to compare the effects. The trial seeks participants with scleroderma affecting both hands similarly, who can attend twice-weekly sessions. This study will assess whether UVA-1 therapy can significantly improve skin and hand flexibility for those with this condition. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could lead to new treatment options for scleroderma.

Will I have to stop taking my current medications?

The trial requires that you do not change your systemic therapy (medications that affect the whole body) during the first 100 days of the study. If you are on photosensitizing medication (medications that make your skin more sensitive to light), you cannot participate in the trial.

What prior data suggests that UVA-1 phototherapy is safe for scleroderma?

Research has shown that UVA-1 phototherapy is generally safe for individuals with skin conditions like scleroderma. In several studies, patients experienced benefits such as improved skin flexibility and enhanced limb movement. One study found that UVA-1 therapy made the skin less stiff and more elastic. Another study reported that patients felt better after 30 sessions of UVA-1 therapy.

Additionally, retrospective studies have shown that UVA-1 is a safe option for treating various skin conditions, with no major safety issues identified. While minor side effects may occur, the overall evidence suggests that this treatment is well-tolerated.

For those considering participation in a trial using UVA-1 phototherapy, the evidence so far indicates it is a safe option for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about UVA-1 phototherapy for scleroderma because it offers a different approach compared to standard treatments like immunosuppressants and steroids. Unlike these options, which mainly suppress the immune system, UVA-1 phototherapy uses a specific wavelength of ultraviolet light to penetrate the skin and may help reduce skin thickening by altering the activity of skin cells directly. This non-invasive method could potentially lead to fewer systemic side effects and provide an alternative for patients who can't tolerate traditional medications.

What evidence suggests that UVA-1 phototherapy might be an effective treatment for scleroderma?

Research has shown that UVA-1 light therapy might improve skin problems in people with scleroderma. One study found that this treatment reduced skin hardening and increased elasticity. Another study reported less stiffness and more flexible skin in patients. Reports also indicate better hand movement after 30 sessions of UVA-1 therapy. In this trial, one hand will receive UVA-1 phototherapy, while the other will remain untreated. Although more research is needed, these findings suggest that UVA-1 could be a promising treatment for scleroderma. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with scleroderma affecting both hands equally, who can attend twice-weekly UVA1 sessions and won't change their systemic therapy during the first 100 days. It's not for those with recent tanning or sun exposure, on photosensitizing meds, unable to complete visits, pregnant or planning pregnancy, using certain topical therapies recently, intolerant to UV light, or disqualified by the investigator.

Inclusion Criteria

I am either male or female.

I can attend two UVA1 therapy sessions every week.

My scleroderma affects both of my hands equally.

Exclusion Criteria

Current pregnancy or planned pregnancy during the study period

I have not used tanning beds or had excessive sun exposure in the last month.

I cannot attend all required study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 30 sessions of UVA-1 therapy on one hand, with the other hand serving as a control with a UV-blocking glove

Approximately 14 weeks

2-3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 12 months post-treatment

12 months

Periodic visits (in-person)

Optional Extension

Participants may opt to receive additional UVA-1 treatments on the untreated hand after the initial treatment phase

What Are the Treatments Tested in This Trial?

Interventions

• UVA-1 Phototherapy

Trial Overview The study tests if UVA-1 Phototherapy improves hand function in scleroderma patients. Participants' dominant or non-dominant hand will receive 30 sessions of high dose UVA-1 treatment. The study measures hand mobility and skin changes before allowing treatment on the other hand. It's a single-blind trial comparing treated vs UV-blocked gloved hands.

How Is the Trial Designed?

Group I: UVA-1 Treated hand Experimental Treatment 1 Intervention

This hand will be treated with UVA-1 phototherapy.

Group II: The untreated hand Active Control 1 Intervention

This hand will be gloved when the patient undergoes UVA-1 phototherapy treatments.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

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

UVA1 a promising approach for scleroderma - PMC This open study showed a positive short- and long-term efficacy of UVA1 with a reduction in sclerotic plaques, an increase in skin elasticity and a reduction of ...

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962203042968

Low-dose UVA1 phototherapy in systemic sclerosis Objective. We sought to confirm data of a pilot study revealing the efficacy of low-dose UVA1 irradiation in acrosclerosis in a larger number of patients.

4. jaad.org jaad.org/article/S0190-9622(03)04296-8/

Low-dose UVA1 phototherapy in systemic sclerosis UVA1 irradiation led to softening of former stiffness reflected by a significant decrease of the hand score, increase of total skin distension, and reduction of ...

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 UV-A1 phototherapy has the potential to become an integral component of scleroderma management, offering a non-invasive and effective option for.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103090/

Effect of UV-A1 Phototherapy Treatment on Scleroderma Overall, patients who received UV-A1 therapy saw beneficial effects, including improved skin elasticity, mobility of extremities, reduced skin ...

7. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1295145/full

The realistic positioning of UVA1 phototherapy after 25 ... The present RWE retrospective study demonstrated that UVA1 phototherapy is an effective and safe treatment option for various skin conditions. However, we have ...