Morphea (Circumscribed Scleroderma)NCT04954573
Study on the Treatment With Water-filtered Infrared-A (wIRA) Radiation in Patients With Morphea and Sclerotic Graft-versus-host Disease
A study testing infrared-A (wIRA) in people with Morphea (Circumscribed Scleroderma) and Sclerotic Graft-versus-host Disease (GVHD), run by Medical University of Graz at 2 sites in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morphea (Circumscribed Scleroderma), Sclerotic Graft-versus-host Disease (GVHD)
- What is being tested?
- infrared-A (wIRA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Jul 2021to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morphea
- Sclerotic graft-versus-host disease (GVHD)
Who cannot join
- Inability to cope with the treatment plan
- Pregnant or breastfeeding women and women of childbearing potential without effective contraception
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Department of Dermatology, Medical University of Graz
Graz, Styria, 8036
Department of Dermatology, Medical University of Vienna
Vienna, 1090
About this study
Official title: 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.
Read the 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.
- Being tested
- infrared-A (wIRA)
- Medical subject headings
- Scleroderma, Localized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared-A (wIRA)Radiation
Local-water filtered infrared-A (wIRA) irradiation
| Study group | Role | What they receive |
|---|---|---|
| Morphea | Other | Not described Receives: Radiation: infrared-A (wIRA) |
| Sclerotic graft-versus-host disease (GVHD) | Other | Not described Receives: Radiation: infrared-A (wIRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of skin sclerosis
as determined by a high-frequency ultrasound device with a 22 MHz applicator
Measured: 20 weeks
Secondary outcomes (4)
Assessment of skin Score
determined by modified Rodnan Skin Score (mRSS) (range, 0 to 51 )
Measured: 20 weeks
Assessment of skin hardness
as determined by durometer
Measured: 20 weeks
Assessment of range of motions
as measured by the range of motions in the presence of contractures (range, 0 to 90 degree)
Measured: 20 weeks
Grade of patient satisfaction
as determined by Patients' Global Impression of Change (PGIC) scale (range, 0 to 7)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jul 2021
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Why it stopped: The study was prematurely terminated due to recruitment difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morphea (Circumscribed Scleroderma)Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Wolf, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954573
- Sponsor's protocol ID
- 30-387 ex 17/18
- Status last verified
- Jan 2025
- First submitted
- 9 Jun 2021
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Treatment With Water-filtered Infrared-A (wIRA) Radiation in Patients With Morphea and Sclerotic Graft-versus-host Disease
- ClinicalTrials.gov ID
- NCT04954573
- Acronym / sponsor ID
- 30-387 ex 17/18
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated due to recruitment difficulties.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphea | Other | Radiation: infrared-A (wIRA) |
| Sclerotic graft-versus-host disease (GVHD) | Other | Radiation: infrared-A (wIRA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Morphea
- Sclerotic graft-versus-host disease (GVHD)
Key exclusion criteria (2 listed)
- Inability to cope with the treatment plan
- Pregnant or breastfeeding women and women of childbearing potential without effective contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infrared-A (wIRA)Local-water filtered infrared-A (wIRA) irradiation | Radiation | Morphea, Sclerotic graft-versus-host disease (GVHD) |
Primary outcome
Intensity of skin sclerosis
Time frame: 20 weeks
as determined by a high-frequency ultrasound device with a 22 MHz applicator
4 secondary outcomes
Assessment of skin Score
Time frame: 20 weeks
Assessment of skin hardness
Time frame: 20 weeks
Assessment of range of motions
Time frame: 20 weeks
Grade of patient satisfaction
Time frame: 20 weeks
Results and safety
The study was stopped early (reason given: The study was prematurely terminated due to recruitment difficulties.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wolf, MD principal investigator
Medical University of Graz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infrared-A (wIRA) in people with Morphea (Circumscribed Scleroderma) and Sclerotic Graft-versus-host Disease (GVHD), run by Medical University of Graz at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was prematurely terminated due to recruitment difficulties.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of skin sclerosis (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.