Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-25 @ 3:12 PM
Study NCT ID:
NCT06458868
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2024-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Endpoint assessors blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective single center open label three parallel group, adaptive randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-25', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Severity Reduction', 'timeFrame': 'Disease Severity', 'description': 'At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment'}], 'secondaryOutcomes': [{'measure': 'Improvevement in the Quality of Life', 'timeFrame': 'Qol', 'description': 'statistically significant improvement in the quality of life of the patients compared to the beginning of the study at the 36the week of the treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bath puva', 'uva', 'psorolene', 'phototherapy', 'local uv a'], 'conditions': ['Psoriasis', 'Contact Dermatitis of Hand']}, 'descriptionModule': {'briefSummary': 'Patients who had an indication for phototherapy were included in this study. The treatment was used as a monotherapy protocol.\n\nThe standard protocol for bathing PUVA involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3% salted (NaCl) water before UVA treatment.\n\nMain tools to assess the efficacy is disease activity scores and quaity of Life scores.', 'detailedDescription': 'Patients who met the criteria for phototherapy were included in this study. The treatment was used as a standalone protocol, with only moisturizer permitted. In order to participate, patients needed to have completed their last systemic treatment at least 2 months prior to the study, and their last topical treatment at least 4 weeks prior.\n\nPatients were randomized using a computer program and assessed at the beginning of therapy, as well as after 12, 24, and 36 sessions. The standard bath-PUVA protocol involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes, and the salt water group received a 3% salt water bath before UVA exposure.\n\nAll patients were educated about their condition and current treatment options. Patients who participated in this study either had contraindications to other therapies or had experienced side effects previously.\n\nThe initial UVA dosage was 0.25 J/cm2, gradually increasing to a maximum of 5 J/cm2. During each evaluation, patients were assessed using various scales and tools to measure the severity of their psoriasis and their quality of life, as well as photographs.\n\nFollowing a pilot study involving 5 patients in each group, a two score reduction in the disease activity score revealed that G power analysis determined that a total of at least 13 patients was needed to achieve 80% power. Ethical approval was obtained before commencing the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged between 18 and 65\n* Clinical diagnosis of Palmoplantar Psoriasis or Contact Dermatitis\n\nExclusion Criteria:\n\n* Individuals under 18 or over 65\n* Pregnancy or breastfeeding\n* History of malignancy\n* Diagnosis of photodermatosis\n* Prescription or use of photoallergenic or phototoxic drugs'}, 'identificationModule': {'nctId': 'NCT06458868', 'briefTitle': 'An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'An Open-label Controlled Trial: Effectiveness of Saltwater-UVA, Tap Water-UVA, and Bath PUVA in the Treatment of Palmoplantar Psoriasis and Contact Dermatitis.', 'orgStudyIdInfo': {'id': 'BALNEOTERAPİ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'bath puva', 'description': 'Patients received the standard protocol of bath PUVA with standard psoralen plus tap water in combination with a phototherapy regimen.'}, {'type': 'EXPERIMENTAL', 'label': 'salt water uva', 'description': 'Patients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen.', 'interventionNames': ['Other: salt water or tap water before UVA']}, {'type': 'EXPERIMENTAL', 'label': 'tap water uva', 'description': 'Patients received tap water in addition to UVA with standard phototherapy regimen.', 'interventionNames': ['Other: salt water or tap water before UVA']}], 'interventions': [{'name': 'salt water or tap water before UVA', 'type': 'OTHER', 'description': 'Instead of using standard bath PUVA, this study investigates the efficacy of tap water or salt water with UVA in the treatment of palmoplantar psoriasis.', 'armGroupLabels': ['salt water uva', 'tap water uva']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University School of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Nihal Kundakcı, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara University Faculty of Medicine, Department of Dermatology and Venereology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If needed, a masked individual participant data is and will be stored in the archives for a duration of 5 years'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hilayda Karakok Kısla', 'investigatorAffiliation': 'Ankara University'}}}}