TerminatedNot Applicable

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

Stopped: The study was prematurely terminated due to recruitment difficulties.

Austria11 participantsStarted 2021-07-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Morphea * Sclerotic graft-versus-host disease (GVHD) Exclusion Criteria: * Inability to cope with the treatment plan * Pregnant or breastfeeding women and women of childbearing potential without effective contraception

What they're measuring

Intensity of skin sclerosis

Timeframe: 20 weeks

Trial details

NCT IDNCT04954573

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-13

View on ClinicalTrials.gov More Morphea (Circumscribed Scleroderma) trials