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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

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ClinicalTrials.gov Identifier: NCT04954573
Recruitment Status : Recruiting
First Posted : July 8, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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.

Condition or disease Intervention/treatment Phase
Morphea (Circumscribed Scleroderma) Sclerotic Graft-versus-host Disease (GVHD) Radiation: infrared-A (wIRA) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on the Treatment With Water-filtered Infrared-A (wIRA) Radiation in Patients With Morphea and Sclerotic Graft-versus-host Disease
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Morphea Radiation: infrared-A (wIRA)
Local-water filtered infrared-A (wIRA) irradiation

Sclerotic graft-versus-host disease (GVHD) Radiation: infrared-A (wIRA)
Local-water filtered infrared-A (wIRA) irradiation




Primary Outcome Measures :
  1. Intensity of skin sclerosis [ Time Frame: 20 weeks ]
    as determined by a high-frequency ultrasound device with a 22 MHz applicator


Secondary Outcome Measures :
  1. Assessment of skin Score [ Time Frame: 20 weeks ]
    determined by modified Rodnan Skin Score (mRSS) (range, 0 to 51 )

  2. Assessment of skin hardness [ Time Frame: 20 weeks ]
    as determined by durometer

  3. Assessment of range of motions [ Time Frame: 20 weeks ]
    as measured by the range of motions in the presence of contractures (range, 0 to 90 degree)

  4. Grade of patient satisfaction [ Time Frame: 20 weeks ]
    as determined by Patients' Global Impression of Change (PGIC) scale (range, 0 to 7)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04954573


Contacts
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Contact: Peter Wolf, MD 00 43 316 385 ext 80315 peter.wolf@medunigraz.at
Contact: Alexandra Gruber-Wackernagel, MD 0043 316 385 ext 13254 peter.wolf@medunigraz.at

Locations
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Austria
Department of Dermatology, Medical University of Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Peter Wolf, MD    031638580315    peter.wolf@medunigraz.at   
Contact: Alexandra Gruber-Wackernagel, MD    00 43 316 385 ext 13254    alexandra.wackernagel@medunigraz.at   
Sub-Investigator: Wolfgang Salmhofer, MD         
Sub-Investigator: Angelika Hofer, MD         
Sub-Investigator: Franz Legat, MD         
Department of Dermatology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Adrian Tanew, MD    +43 1 40400 ext 77070    adrian.tanew@gmail.com   
Contact: Paul Jauker, MD    +43 1 40400 ext 77070    paul.jauker@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Peter Wolf, MD Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04954573    
Other Study ID Numbers: 30-387 ex 17/18
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scleroderma, Localized
Graft vs Host Disease
Sclerosis
Immune System Diseases
Connective Tissue Diseases
Skin Diseases
Pathologic Processes