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UVA-1 for treatment of skin tightening and improvement of hand function in scleroderma: a randomized, intra-patient, Dominant/Non-dominant hand clinical trial.

NCT ID NCT04875078

Sponsor: University of Utah Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Nov 02, 2026 · Last updated Nov 03, 2026 · Updated 1 time

Summary

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 is a randomized, investigator-blinded, intra-patient, UV-blocking glove-controlled clinical trial. 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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma scleroderma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scleroderma

Contacts and locations

Locations

  • University of Utah MidValley Dermatology

    Murray, Utah, 84107, United States

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