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

Last updated: June 22, 2022
Sponsor: Szeged University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psoriasis And Psoriatic Disorders

Rosacea

Warts

Treatment

N/A

Clinical Study ID

NCT05431959
SZEGEDU
  • Ages 18-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 metabolicdisorders (diabetes mellitus, hyperuricaemia,hyperlipoproteinaemia); acute febrileinfections; cutaneous suppuration;pregnancy; decompensated psychosis/neurosis,malignancy, urine and stool incontinent, unconsciousness, alcoholic influence, andlack of compliance.

Study Design

Total Participants: 16
Study Start date:
July 25, 2021
Estimated Completion Date:
August 15, 2022

Study 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.

Connect with a study center

  • Tamas Bender

    Budapest, 1025
    Hungary

    Active - Recruiting

  • Ágota Kulisch, MD, PhD

    Hévíz, 8380
    Hungary

    Active - Recruiting

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