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

NCT05431959 | Unknown

• 1 other identifier: SZEGEDU
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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

Conditions

Plaque Psoriasis

Keywords

balneotherapy; microbiome

Outcome Measures

Primary Outcomes (2)

• 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

  baseline to week 3

• 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.

  baseline to week 3

Secondary Outcomes (2)

• 1. Beta diversity

  baseline to week 3

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

  baseline to week 3

Study Arms (1)

Self-controlled

EXPERIMENTAL

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

Interventions

balneotherapy OTHER

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.

Self-controlled

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Szeged University: lead

Study Sites (2)

Tamas Bender

Budapest, 1025, Hungary

RECRUITING

Ágota Kulisch, MD, PhD

Hévíz, 8380, Hungary

RECRUITING

Related Publications (5)

• 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.

  PMID: 33670115 BACKGROUND

• 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.

  PMID: 26659932 BACKGROUND

• 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.

  PMID: 33236826 BACKGROUND

• 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.

  PMID: 33812489 RESULT

• 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.

  PMID: 32869298 RESULT

MeSH Terms

Interventions

Balneology

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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 Record Dates

• First Submitted: June 8, 2022
• First Posted: June 24, 2022
• Study Start: July 25, 2021
• Primary Completion: June 17, 2022
• Study Completion: August 15, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2)