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

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

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.

Study Overview

• Status: Terminated
• Conditions: Morphea (Circumscribed Scleroderma); Sclerotic Graft-versus-host Disease (GVHD)
• Intervention / Treatment: Radiation: infrared-A (wIRA)

Detailed Description

A sclerotic plaque or area of skin on the right side of the body and contralaterally on the left half of the body (each maximum size: 25 cm in diameter, corresponding to the radiation field of the Hydrosun® heater 750) is selected. The assignment of one side of the body to irradiation or non-irradiation is randomized (using the MedUni Graz randomizer). The plaque randomized for irradiation is irradiated on 3 days a week for 30 minutes each time. The treatment period extends over 20 weeks, the total number of radiation treatments is therefore 60. If the patients cannot come to the radiation treatment, home therapy can be carried out according to the same treatment scheme. The radiation at the clinic is carried out with a Hydrosun® lamp 750, the home treatment with the Hydrosun® 575home (Hydrosun Medizintechnik GmbH, Mauchener Str. 14, D-79379 Muellheim, Germany). The radiation intensity at the distance of 33 cm between the device and the skin surface standardized by a distance rod is 200 mW / cm2 (visible light 50 mW / cm2, infrared A 150 mW / m2). The contralateral plaque or skin area of comparable clinical characteristics and duration of existence was included as an unirradiated control. Target and control areas will be photo-documented in the course of the study. Before the first irradiation, after the 30th and after the 60th irradiation, the skin thickness and hardness of the target and control regions are measured by a blinded examiner and the skin status including mRSS (Rodnan skin score) is recorded. In addition, at the beginning and at the end of the study, the patient's assessment of the effect (PGIC scale) and tolerability of the therapy is asked. Any side effects of the irradiation are continuously documented.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Dermatology, Medical University of Vienna
  • Styria
    • Graz, Styria, Austria, 8036
      • Department of Dermatology, Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Morphea	Radiation: infrared-A (wIRA); Local-water filtered infrared-A (wIRA) irradiation
Other: Sclerotic graft-versus-host disease (GVHD)	Radiation: infrared-A (wIRA); Local-water filtered infrared-A (wIRA) irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of skin sclerosis	as determined by a high-frequency ultrasound device with a 22 MHz applicator	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of skin Score	determined by modified Rodnan Skin Score (mRSS) (range, 0 to 51 )	20 weeks
Assessment of skin hardness	as determined by durometer	20 weeks
Assessment of range of motions	as measured by the range of motions in the presence of contractures (range, 0 to 90 degree)	20 weeks
Grade of patient satisfaction	as determined by Patients' Global Impression of Change (PGIC) scale (range, 0 to 7)	20 weeks

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Peter Wolf, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): February 13, 2024
• Study Completion (Actual): February 13, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Immune System Diseases; Skin Diseases; Sclerosis; Graft vs Host Disease; Scleroderma, Localized
• Other Study ID Numbers: 30-387 ex 17/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No