Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 4:31 PM
Study NCT ID:
NCT05431959
Status:
UNKNOWN
Last Update Posted:
2022-06-24
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Sulphur Mineral, Thermal Water on Skin Microbiome in Plaque Psoriasis, a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001452', 'term': 'Balneology'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Alpha diversity', 'timeFrame': 'baseline to week 3', 'description': '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'}, {'measure': '2. Change in microbiota diversity before and after balneotherapy treatment', 'timeFrame': 'baseline to week 3', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '1. Beta diversity', 'timeFrame': 'baseline to week 3', 'description': 'Inter-sample genus composition differences by the Bray-Curtis beta-diversity metric'}, {'measure': '2. The Psoriasis Area and Severity Index (PASI) allows evaluating the extent and severity of skin symptoms of psoriasis.', 'timeFrame': 'baseline to week 3', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['balneotherapy', 'microbiome'], 'conditions': ['Plaque Psoriasis']}, 'referencesModule': {'references': [{'pmid': '33670115', 'type': 'BACKGROUND', 'citation': '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': '26659932', 'type': 'BACKGROUND', 'citation': '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': '33236826', 'type': 'BACKGROUND', 'citation': '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': '33812489', 'type': 'RESULT', 'citation': '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': '32869298', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of plaque psoriasis for at least 6 months before the Baseline Visit\n* Subject has stable mild to moderate plaque psoriasis\n\nExclusion Criteria:\n\n* subject has systemic therapy for plaque psoriasis\n* balneotherapy within 3 months prior the enrollement\n* systemic/local glucocorticoid therapy within 1 month prior the enrollment\n* 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.'}, 'identificationModule': {'nctId': 'NCT05431959', 'briefTitle': 'Evaluation of the Effect of Sulphur Mineral, Thermal Water on Skin Microbiome in Plaque Psoriasis, a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Szeged University'}, 'officialTitle': 'Evaluation of the Effect of Sulphur Mineral, Thermal Water on Skin Microbiome in Plaque Psoriasis, a Pilot Study', 'orgStudyIdInfo': {'id': 'SZEGEDU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-controlled', 'description': "The skin microbiome was collected by swabbing method from the crook of the arm (normal skin) and the nearest plaque's surface.\n\nBalneotherapy 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.", 'interventionNames': ['Other: balneotherapy']}], 'interventions': [{'name': 'balneotherapy', 'type': 'OTHER', '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.', 'armGroupLabels': ['Self-controlled']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1025', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Tamas Bender', 'role': 'CONTACT', 'email': 'bender.tamas@t-online.hu', 'phone': '+36205858918'}, {'role': 'CONTACT', 'phone': '36205858918'}], 'facility': 'Tamas Bender', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '8380', 'city': 'Hévíz', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Tamas Bender, MD, PhD, DSc', 'role': 'CONTACT', 'email': 'bender.tamas@t-online.hu', 'phone': '36205858918'}, {'role': 'CONTACT', 'phone': '36205858918'}], 'facility': 'Ágota Kulisch, MD, PhD', 'geoPoint': {'lat': 46.79031, 'lon': 17.18408}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szeged University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Tamás Bender', 'investigatorAffiliation': 'Szeged University'}}}}