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

Part of paid clinical trials in Murray, Utah.

Sponsor
University of Utah
Study ID
NCT04875078
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UVA-1 Phototherapy — DEVICE
    UVA-1 Phototherapy treatments

Study Details

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 Dates

Start date
Dec 12, 2020
Status verified
Dec 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UVA-1 Treated hand
    This hand will be treated with UVA-1 phototherapy.
  • No Intervention: The untreated hand
    This hand will be gloved when the patient undergoes UVA-1 phototherapy treatments.

Primary Outcome Measure

HAMIS score of treated hand compared to the HAMIS score of the untreated hand after 30 UVA-1 treatments have been completed. [ Time Frame: Approximately 100 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Utah MidValley DermatologyMurrayUtah84107-

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University of Utah MidValley Dermatology· Murray, UT

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