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

University of Szeged (SZTE)

Status: Enrolling

Conditions: Plaque Psoriasis

Treatments: Other: balneotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05431959

SZEGEDU

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Self-controlled

Experimental group

Description:

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.

Treatment:

Other: balneotherapy