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

NCT04954573 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-01-30

No results posted yet for this study

Summary

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.

Conditions

  • Morphea (Circumscribed Scleroderma)
  • Sclerotic Graft-versus-host Disease (GVHD)

Interventions

RADIATION

infrared-A (wIRA)

Local-water filtered infrared-A (wIRA) irradiation

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Peter Wolf, MD · Medical University of Graz

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-02-13
Completion
2024-02-13

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954573 on ClinicalTrials.gov