Low-dose radon hyperthermia therapy in atopic dermatitis
| ISRCTN | ISRCTN40955970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40955970 |
| Secondary identifying numbers | E2126 |
- Submission date
- 24/06/2021
- Registration date
- 29/06/2021
- Last edited
- 27/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Atopic dermatitis (AD) is an inflammatory skin disease, mainly characterized by pruritus, skin dryness, and eczema. For some patients, conventional therapy methods are insufficient. These patients might benefit from Low-dose Radon Hyperthermia (LDRnHT) therapy. This is a well-recognized treatment method for inflammatory diseases in various compartments of the human body. Clinical studies demonstrated that LDRnHT- therapy can reduce pain, enhance functionality and positively shift crucial blood parameters. Many positive single reports from AD patients support this theory, but there are no clinical studies so far. The purpose of this pilot study is to evaluate whether AD patients can evidently benefit from LDRnHT.
Who can participate?
Patients aged 18 -70 years with chronic, moderate to severe AD
What does the study involve?
All study participants have to pass an initial examination (T0) at the Department of Dermatology and Allergology at the University Hospital Salzburg, Austria. Patients enrolled are randomised into a control and an intervention group. Participants attend a two-week cure stay in Bad Gastein. The intervention group receives eight sessions of LDRnHT in the Gastein Healing Gallery (average radon activity ≈44 kBq/m3; ambient temperature 37-41.5° C; air humidity ≥ 70%). The control group receives sauna treatments with the same ambient temperature and humidity but without radon. Short term modifications of skin condition and specific blood parameters are assessed, as well as questionnaires for skin condition and quality of life (Qol), comparing the initial situation (T0) to immediate post-radon-therapy (T1).
Long-term effects are documented in follow-up examinations at three, six and nine months after T1 (T2/T3/T4, respectively). At every examination, skin condition is assessed by a dermatologist using the SCORing Atopic Dermatitis rating tool, and blood samples and questionnaires are collected. Patients are asked to fill out the Patient Oriented SCORAD questionnaire using a computer or smartphone application, and the SKINDEX-29 tool to measure of the effect of the skin disease on quality of life. The EQ-5D-5L and VAS questionnaires are used to assess Quality of Life (Qol). At T0 and T2. If the condition of a participant becomes worse, the dermatologist is authorized to assign a different therapy and end a patient’s participation in the study.
In this pilot study, molecular parameters shall be investigated which reflect the therapeutic effects of LDRnHT in AD patients. The results from this pilot study shall build a basis for the development of further hypotheses and larger studies investigating LDRnHT as a therapy option for AD.
What are the possible benefits and risks of participating?
Patients receive a cost-free cure stay in Bad Gastein. Improvement of skin condition might be achieved through LDRnHT.
Possible worsening of skin condition might occur due to elevated air humidity and temperature (ambient temperature 37-41.5°C; air humidity ≥ 70%) during treatments.
Where is the study run from?
The study is run from the Gastein Research Institute (Paracelsus Medical University in Salzburg) which is part of the Center for Physiology, Pathophysiology and Biophysics (Salzburg and Nuremberg, Austria and Germany), in cooperation with the Gastein Healing Gallery in Böckstein, Austria.
When is the study starting and how long is it expected to run for?
August 2016 to December 2020
Who is funding the study?
Cure stays and treatment funded by:
Gasteiner Kur-, Reha und Heilstollen Betriebsges.m.b.H. (Austria)
Other funding:
Gastein Research Institute, Center for Physiology, Pathophysiology and Biophysics, Salzburg and Nuremberg - Salzburg, Paracelsus Medical University Salzburg (Austria)
Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH (Austria)
Who is the main contact?
Dr Markus Ritter, markus.ritter@pmu.ac.at
Contact information
Public
Strubergasse 22
Salzburg
5020
Austria
| Phone | +43 662 2420-80511 |
|---|---|
| julia.fuchs@pmu.ac.at |
Scientific
Strubergasse 22
Salzburg
5020
Austria
| Phone | +43 662 2420-80511 |
|---|---|
| julia.fuchs@pmu.ac.at |
Study information
| Study design | Single-centre interventional open randomized explorative prognostic longitudinal pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | ISRCTN40955970_PIS_v4_12Jun2019.pdf |
| Scientific title | Study for the effectivity of low-dose radon hyperthermia therapy in the Gastein healing gallery on atopic dermatitis |
| Study hypothesis | This pilot study outcome shall provide information for further generation of hypotheses |
| Ethics approval(s) | Approved 25/01/2017, Ethikkommission für das Bundesland Salzburg (Sebastian-Stief-Gasse 2 5020 Salzburg, Austria), +43-(0)662-8042-2375, ethikkommission@salzburg.gv.at), ref: E.-Nr. 2126 |
| Condition | Effectivity of low-dose radon hyperthermia therapy on atopic dermatitis |
| Intervention | Patients with Atopic Dermatitis (AD) are recruited via the department of dermatology of the Salzburger Landeskliniken (Prim. Dr. Johann Bauer, SALK). Patients are randomised to control (sauna treatment) and interventional groups (Low-dose Radon Hyperthermia Therapy (LDRnHT) in the Gastein Healing Gallery). The randomisation process was carried out, regardless of any specific patient characteristics, via permuted block randomisation (block sizes: 7, 6, and 4). Blood samples, questionnaires and survey of drug consumption were collected for timepoints before, directly after cure stay and three, six, and nine months after end of the cure stay. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | SCORAD (SCORing Atopic Dermatitis) questionnaire for specific assessment of skin condition in AD at before, directly after cure stay and 3, 6, and 9 months after the end of the cure stay. |
| Secondary outcome measures | Measured before, directly after cure stay, and three, six, and nine months after the end of the cure stay: 1. Quality of life (EQ-5D-5L) 2. Skin condition (SKINDEX-29) 3. Analysis of blood samples (MDC/CCL22, CTACK/CCL27, TARC/CCL17, IgE, IL-4, IL-13) |
| Overall study start date | 16/08/2016 |
| Overall study end date | 08/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 32 |
| Total final enrolment | 34 |
| Participant inclusion criteria | 1. Atopic Dermatitis, from chronic moderate to severe disease state. (mild: SCORAD <25, moderate SCORAD 25-50, severe SCORAD >50) 2. Patient SCORAD value must be between 25 and 50 for inclusion 3. AD must be diagnosed and verified by a dermatologist 4. Age range 18 - 70 years 5. Signed Informed Consent must be obtained from each patient 6. Patients must be able to fill out a questionnaire by themselves |
| Participant exclusion criteria | 1. Pregnancy or breast feeding period 2. Incompatibility of patients to treatment methods 3. Erosions, ulcers 4. Viral or bacterial superinfections 5. Severe internal diseases 6. Consumption of potential photosensitizers 7. Concomitant or past malignant skin tumors 8. Radon therapy or similar radiation (UV/light) treatment within the past year 9. Consumption of oral immunosuppressive drugs (within 6 months before entering the study) 10. Claustrophobia |
| Recruitment start date | 25/01/2017 |
| Recruitment end date | 06/07/2020 |
Locations
Countries of recruitment
- Austria
- Germany
Study participating centres
Böckstein
Bad Gastein
5645
Austria
Salzburg
5020
Austria
Salzburg
5020
Austria
Sponsor information
Hospital/treatment centre
St. Veiter Straße 46
St. Veit im Pongau
5621
Austria
| Phone | +43 (0)5 7255 - 46000 |
|---|---|
| aed.lk-stveit@salk.at | |
| Website | https://salk.at/Landesklinik_St_Veit.html |
"ROR" |
https://ror.org/0500kmp11 |
Hospital/treatment centre
Müllner Hauptstraße 48
Salzburg
5020
Austria
| Phone | +43 (0)5 7255-0 |
|---|---|
| joh.bauer@salk.at | |
| Website | https://www.salk.at/ |
|
"ROR" |
https://ror.org/0500kmp11 |
University/education
Gastein Research Institute, Center for Physiology, Pathophysiology and Biophysics
Strubergasse 22
Salzburg
5020
Austria
| Phone | +43 662 2420 80500 |
|---|---|
| markus.ritter@pmu.ac.at | |
| Website | https://www.pmu.ac.at/ |
|
"ROR" |
https://ror.org/022zhm372 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Paracelsus Medical University, PMU
- Location
- Austria
No information available
No information available
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v4 | 12/06/2019 | 08/07/2021 | No | Yes |
| Protocol file | In German | 31/12/2017 | 10/08/2022 | No | No |
Additional files
- ISRCTN40955970_PIS_v4_12Jun2019.pdf
- Uploaded 08/07/2021
- ISRCTN40955970_Protocol_31Dec2017.pdf
- In German
Editorial Notes
27/08/2024: The intention to publish date was changed from 30/08/2024 to 30/11/2024.
28/02/2024: The intention to publish date has been changed from 30/06/2023 to 30/08/2024.
15/03/2023: The public and scientific contacts were changed.
10/08/2022: The following changes have been made:
1. Protocol file uploaded.
2. The intention to publish date has been changed from 30/11/2021 to 30/06/2023.
10/05/2022: The study contact has been updated.
08/07/2021: The participant information sheet has been uploaded.
29/06/2021: Trial's existence confirmed by Ethikkommission für das Bundesland Salzburg.
