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Plaque PsoriasisNCT05431959

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

A study testing balneotherapy in people with Plaque Psoriasis, run by Szeged University at 2 sites in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
balneotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesHungary
Study dates
25 Jul 2021to 15 Aug 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Hungary2 sites, 2 recruiting

  • Tamas Bender

    Budapest, 1025

    Tamas Bender, +36205858918, bender.tamas@t-online.hu

    36205858918

    Recruiting

  • Ágota Kulisch, MD, PhD

    Hévíz, 8380

    Tamas Bender, MD, PhD, DSc, 36205858918, bender.tamas@t-online.hu

    36205858918

    Recruiting

Other trials in Hungary

About this study

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

Read the 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.

Being tested
balneotherapy
Keywords
balneotherapy, microbiome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • balneotherapyOther

    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.

Study groups in NCT05431959
Study groupRoleWhat they receive
Self-controlledExperimentalThe 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.
Receives: Other: balneotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Alpha diversity

    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

    Measured: baseline to week 3

  2. 2. Change in microbiota diversity before and after balneotherapy treatment

    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.

    Measured: baseline to week 3

Secondary outcomes (2)

  1. 1. Beta diversity

    Inter-sample genus composition differences by the Bray-Curtis beta-diversity metric

    Measured: baseline to week 3

  2. 2. The Psoriasis Area and Severity Index (PASI) allows evaluating the extent and severity of skin symptoms of psoriasis.

    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.

    Measured: baseline to week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start25 Jul 2021
  3. Primary completion17 Jun 2022
  4. Study completion15 Aug 2022 (estimated)

Resources

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
Not applicable
Intervention model
Single group
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)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431959
Sponsor's protocol ID
SZEGEDU
Status last verified
Jun 2022
First submitted
8 Jun 2022
Last updated
24 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 33670115

  • 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.

    PubMed 26659932

  • 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.

    PubMed 33236826

  • 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.

    PubMed 33812489

  • 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.

    PubMed 32869298

Questions about this trial

What is this clinical trial studying?

A study testing balneotherapy in people with Plaque Psoriasis, run by Szeged University at 2 sites in Hungary.

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 4 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: status not confirmed, as of the sponsor's last update on 24 Jun 2022. 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 Hungary. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Alpha diversity (time frame: baseline to week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431959, which also lists 5 linked publications.

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 24 Jun 2022.

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