UVA-1 for Treatment of Skin Tightening and Improvement of Hand Function in Scleroderma

Enrolling by invitation · Not applicable

Conditions studied: Scleroderma

In brief

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.

Key facts

Study ID

NCT04875078

Run by

University of Utah

People needed

30

Starts

2020-12-12

Expected to finish

2025-12-01

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be able to understand and provide written informed consent
• Scleroderma skin involvement affecting both hands approximately equally
• Age of at least 18-years-old
• Male or female
• Ability to engage in twice weekly UVA1 sessions
• No changes in systemic therapy during the first 100 days of the study period

You may not qualify if…

• On photosensitizing medication
• Inability to complete study visits
• UV light therapy in the 4 weeks prior to entering the study
• Commercial tanning or excessive sun exposure in the 4 weeks prior to entering the study
• Current pregnancy or planned pregnancy during the study period
• Use of topical therapies other than emollients (suprapotent corticosteroids) in the 2 weeks prior to entering the study
• History of intolerance to ultraviolet light
• Any other condition that will disqualify the patient from the study in the opinion of the investigator

Where it is running

• University of Utah MidValley Dermatology — Murray, Utah, United States

Full record on ClinicalTrials.gov

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