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Compensation: Varies

Number of Visits: 3

Duration: Approximately 14 weeks

30 Participants Needed

UVA-1 Phototherapy for Scleroderma

Overseen ByAdrianne 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

UVA-1 has been reported to be beneficial to skin changes in scleroderma in several case reports and a few small studies. (Jacobe 2020) Interpretation of these reports has been difficult based on the small numbers of subjects involved and the non-blinded non-randomized nature of the reports. In a single controlled study with half-side comparison of 9 patients, the investigators could not demonstrate improvement with UVA-1 in the treated hand. (Thomas 2007) This study was limited by a small number of patients and the long disease duration prior to treatment (mean of 13 years). A more recent report of a patient with scleroderma for 2.5 years and severe acrosclerosis that responded to 21 sessions of UVA-1 with improved mobility and functionality renews interest in this treatment modality. (Cuenca-Barrales 2019) In this trial patients will be randomized to have their dominant or non-dominant hand undergo 30 sessions of UVA1 therapy . We will assess patient's hand mobility, hand function, skin hardening (assessed by durometer measurements), skin thickness, as well as patient reported outcomes to determine efficacy. This study will use a single-blind, prospective, randomized (dominant/non-dominant hand) comparator design to assess the effect of high dose (80-120 J/cm2) UVA1 therapy on hand function in scleroderma in a paired t-test design. This study will be placebo-controlled (with a UV-blocking gloved hand), cross-over, randomized clinical trial. Following the initial treatment period (30 treatments), patients will have the option to undergo the same high dose UVA1 treatment protocol on the untreated control hand. A follow up period of 12 months following completion of UVA1 therapy will prospectively follow patients to monitor for relapse of their disease to assess the durability of the clinical response to UVA1 therapy on hand 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 data supports the effectiveness of the treatment UVA-1 Phototherapy for Scleroderma?

Several studies have shown that UVA-1 phototherapy can improve skin conditions in people with scleroderma, with improvements noted in skin scores and lesion appearance. Although more rigorous studies are needed, existing research suggests that UVA-1 phototherapy is a promising treatment option for this condition.¹ ² ³ ⁴ ⁵

Is UVA-1 phototherapy safe for humans?

The safety of UVA-1 phototherapy has been studied for various skin conditions, including scleroderma, since 1995. While there are no large, rigorous studies specifically on safety, it has been used in multiple studies without major safety concerns reported.¹ ² ³ ⁶ ⁷

How is UVA-1 phototherapy different from other treatments for scleroderma?

UVA-1 phototherapy is unique because it uses ultraviolet light to treat scleroderma, a condition with no standard treatment. It has been shown to improve skin lesions in both localized and systemic forms of the disease, offering a non-invasive option that targets the skin directly.¹ ³ ⁵ ⁶ ⁸

Eligibility Criteria

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.

I am 18 years old or older.

See 3 more

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.

See 5 more

Timeline

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

Treatment Details

Interventions

UVA-1 Phototherapy

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: UVA-1 Treated handExperimental Treatment1 Intervention

This hand will be treated with UVA-1 phototherapy.

Group II: The untreated handActive Control1 Intervention

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