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NCT04954573

Study on the Treatment With Water-filtered Infrared-A (wIRA) Radiation in Patients With Morphea and Sclerotic Graft-versus-host Disease

Terminated NA Last updated 30 January 2025
What this trial tests

NA trial testing infrared-A (wIRA) in Morphea (Circumscribed Scleroderma) in 11 participants. Terminated before completion.

Timeline
1 July 2021
Primary endpoint
13 February 2024
13 February 2024

Quick facts

Lead sponsorMedical University of Graz
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment11
Start date1 July 2021
Primary completion13 February 2024
Estimated completion13 February 2024
Sites2 locations across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Graz

Who can join

Adults 18 to 80, any sex, with Morphea (Circumscribed Scleroderma) or Sclerotic Graft-versus-host Disease (GVHD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, intra-individual comparative study to evaluate the effectiveness of local-water filtered infrared-A (wIRA) irradiation (applied by Hydrosun® radiator 750 for radiation at the clinic, or Hydrosun® 575home for home treatment) in patients with morphea or sclerotic GVHD (Graft-versus-host Disease). The purpose of the study is to determine whether wIRA irradiation can reduce fibrotic skin alterations in circumscribed scleroderma (morphea) or chronic graft versus host disease. wIRA irradiation is applied for 30 minutes 3 times per week for 20 weeks to a diseased skin area and a lesional skin on contralateral body site remains untreated. A total of 22 patients (20 evaluable patients with an expected drop-out rate of 10%) are to be included in this study. Group A: 11 patients with plaque morphea Group B: 11 patients with sclerotic GVHD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Morphea: The 2023 update.
    Papara C, De Luca DA, Bieber K, Vorobyev A, et al · · 2023 · cited 55× · PMID 36860340 · DOI 10.3389/fmed.2023.1108623

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