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Evaluation of the Effect of Sulphur Mineral, Thermal Water on Skin Microbiome in Plaque Psoriasis, a Pilot Study

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ClinicalTrials.gov Identifier: NCT05431959
Recruitment Status : Recruiting
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Tamás Bender, Szeged University

Brief Summary:
In this study the effects of balneotherapy in Lake Hévíz, 36℃ sulphur, carbonate, calcium, magnesium, hydrogen carbonate and very light radon-content thermal, mineral water on skin microbiome and Psoriasis Area and Severity Index (PASI) in patients with plaque psoriasis

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Other: balneotherapy Not Applicable

Detailed Description:

Psoriasis is a chronic inflammatory skin disease. It is associated with several important medical conditions, including psoriatic arthritis, and cardiometabolic syndrome. Its most common form, chronic plaque.The aim of this study is to evaluate how Lake Hévíz sulphur thermal mineral water therapy influences the composition of microbial communities that colonizes skin in patients with psoriasis, and the extent and severity of skin symptoms of psoriasis.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Sulphur Mineral, Thermal Water on Skin Microbiome in Plaque Psoriasis, a Pilot Study
Actual Study Start Date : July 25, 2021
Actual Primary Completion Date : June 17, 2022
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Other: 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.




Primary Outcome Measures :
  1. 1. Alpha diversity [ Time Frame: baseline to week 3 ]
    Determination of microbiom in samples (bacterial DNA are isolated from the skin to determine the microbial composition) Number of species with Shannon-, Simpson and Chao1 indexes

  2. 2. Change in microbiota diversity before and after balneotherapy treatment [ Time Frame: baseline to week 3 ]
    Change in alpha diversity before and after treatment:to compare normal samples before and after treatment, to compare psoriasis samples before and after treatment and the comparison of normal and psoriasis samples before treatment.Differences in genus abundances to determine with the core function of the microbiome R package (Lahti et al., 2019), with detection 100 and prevalence 0.1.


Secondary Outcome Measures :
  1. 1. Beta diversity [ Time Frame: baseline to week 3 ]
    Inter-sample genus composition differences by the Bray-Curtis beta-diversity metric

  2. 2. The Psoriasis Area and Severity Index (PASI) allows evaluating the extent and severity of skin symptoms of psoriasis. [ Time Frame: baseline to week 3 ]
    Percentage of Participants With a 50% Reduction From Baseline Psoriasis Area and Severity Index (PASI 50) at Week 3. The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of plaque psoriasis for at least 6 months before the Baseline Visit
  • Subject has stable mild to moderate plaque psoriasis

Exclusion Criteria:

  • subject has systemic therapy for plaque psoriasis
  • 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.

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): NCT05431959


Locations
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Hungary
Tamas Bender Recruiting
Budapest, Hungary, 1025
Contact: Tamas Bender    +36205858918    bender.tamas@t-online.hu   
Contact    36205858918      
Ágota Kulisch, MD, PhD Recruiting
Hévíz, Hungary, 8380
Contact: Tamas Bender, MD, PhD, DSc    36205858918    bender.tamas@t-online.hu   
Contact    36205858918      
Sponsors and Collaborators
Szeged University
Publications of Results:
Other Publications:
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Responsible Party: Tamás Bender, Professor of Medicine, Szeged University
ClinicalTrials.gov Identifier: NCT05431959    
Other Study ID Numbers: SZEGEDU
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In this study the effects of balneotherapy in Lake Hévíz, 36℃ sulphur, carbonate, calcium, magnesium, hydrogen carbonate and very light radon-content thermal, mineral water on skin microbiome and Psoriasis Area and Severity Index (PASI) in patients with plaque psoriasis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tamás Bender, Szeged University:
balneotherapy
microbiome
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases