NCT04875078Completed
UVA-1 for Treatment of Skin Tightening and Improvement of Hand Function in Scleroderma
UVA-1 for Treatment of Skin Tightening and Improvement of Hand Function in Scleroderma: a Randomized, Intra-patient, Dominant/Non-dominant Hand Clinical Trial.
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 30 Apr 2021
- Start date
- 12 Dec 2020
- Primary completion date
- 31 Mar 2023
- Lead sponsor
- University of Utah
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04875078
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From 12 Dec 2020 to the primary completion date, 31 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On photosensitizing medication
- 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
- Use of topical therapies other than emollients (suprapotent corticosteroids) in the 2 weeks prior to entering the study
Other illness
- History of intolerance to ultraviolet light
- Any other condition that will disqualify the patient from the study in the opinion of the investigator
Other
- Inability to complete study visits
- Current pregnancy or planned pregnancy during the study period
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Utah Midvalley Dermatology Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.