Evaluation of the Effect of Sulphur Mineral, Thermal Water on Skin Microbiome in Plaque Psoriasis, a Pilot Study
NCT ID: NCT05431959
Last Updated: 2022-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
16 participants
INTERVENTIONAL
2021-07-25
2022-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Scalp Microbiota of the Psoriasis and Seborrheic Dermatitis Patients
NCT03807453
Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis
NCT02713711
Climatotherapy Versus Topical Combination of Corticosteroids and Salicylic Acid in Treatment of Psoriasis
NCT03156062
Evaluation The Effect of NB-UVB and Methotrexate on The Level of Serum Gelsolin in Psoriatic Patients
NCT06712238
An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.
NCT06458868
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The planned participants number is 16 outpatients between 18 and 70 years of age with mild to moderate psoriasis. The balneotherapy takes place in Lake Hévíz, five times a week for three weeks.
The skin microbiome is collected from two different place by swabbing method from the patient. One sample is collected from the normal skin, which is not affected by psoriasis (crook of the arm), the second sample is collected from psoriatic plaque of the elbow. The samples is processed for a sequence-based microbiome analysis.
The skin microbiome is evaluated by the analysis of the sample metagenome compositions, and the activity of psoriasis is evaluated on The Psoriasis Area and Severity Index (PASI), is taken at week 0., at week 3.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Self-controlled
The skin microbiome was collected by swabbing method from the crook of the arm (normal skin) and the nearest plaque's surface.
Balneotherapy in Lake Hévíz, 36℃ sulphur, carbonate, calcium, magnesium, hydrogen carbonate and very light radon-content thermal-mineral water 15 times in 3 weeks 30-minute therapy sessions. The total mineral substance of the water is 754 mg/l.
balneotherapy
immersion in Lake Hévíz, 36℃ sulphur, carbonate, calcium, magnesium, hydrogen carbonate and very light radon-content thermal-mineral water 15 times in 3 weeks 30-minute therapy sessions. The total mineral substance of the water is 754 mg/l.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
balneotherapy
immersion in Lake Hévíz, 36℃ sulphur, carbonate, calcium, magnesium, hydrogen carbonate and very light radon-content thermal-mineral water 15 times in 3 weeks 30-minute therapy sessions. The total mineral substance of the water is 754 mg/l.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject has stable mild to moderate plaque psoriasis
Exclusion Criteria
* balneotherapy within 3 months prior the enrollement
* systemic/local glucocorticoid therapy within 1 month prior the enrollment
* general contraindications to balneotherapy: decompensated cardiovasculardisease; unstable hypertension, angina pectoris; uncontrolled endocrinedisease (hyperthyroidism, hyperparathyroidism); other uncontrolledand unstable metabolic disorders (diabetes mellitus, hyperuricaemia,hyperlipoproteinaemia); acute febrile infections; cutaneous suppuration;pregnancy; decompensated psychosis/neurosis, malignancy, urine and stool incontinent, unconsciousness, alcoholic influence, and lack of compliance.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Szeged University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tamás Bender
Professor of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tamas Bender
Budapest, , Hungary
Ágota Kulisch, MD, PhD
Hévíz, , Hungary
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
De Pessemier B, Grine L, Debaere M, Maes A, Paetzold B, Callewaert C. Gut-Skin Axis: Current Knowledge of the Interrelationship between Microbial Dysbiosis and Skin Conditions. Microorganisms. 2021 Feb 11;9(2):353. doi: 10.3390/microorganisms9020353.
Martin R, Henley JB, Sarrazin P, Seite S. Skin Microbiome in Patients With Psoriasis Before and After Balneotherapy at the Thermal Care Center of La Roche-Posay. J Drugs Dermatol. 2015 Dec;14(12):1400-5.
Peinemann F, Harari M, Peternel S, Chan T, Chan D, Labeit AM, Gambichler T. Indoor balneophototherapy for chronic plaque psoriasis: Abridged Cochrane Review. Dermatol Ther. 2021 Jan;34(1):e14588. doi: 10.1111/dth.14588. Epub 2020 Dec 2.
Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 3;397(10281):1301-1315. doi: 10.1016/S0140-6736(20)32549-6.
Darlenski R, Bogdanov I, Kacheva M, Zheleva D, Demerdjieva Z, Hristakieva E, Fluhr JW, Tsankov N. Disease severity, patient-reported outcomes and skin hydration improve during balneotherapy with hydrocarbonate- and sulphur-rich water of psoriasis. J Eur Acad Dermatol Venereol. 2021 Mar;35(3):e196-e198. doi: 10.1111/jdv.16908. Epub 2020 Sep 17. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SZEGEDU
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.