Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-28 @ 9:09 PM
Study NCT ID:
NCT06625918
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2024-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ultraviolet B Exposure Using a Ultraviolet Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Total white blood cells its differential', 'timeFrame': '2 weeks and 4 weeks', 'description': '2 weeks and 4 weeks treatment of total white blood cells and its differential counts such as eosinophils, basophils, lymphocytes, etc from baseline'}], 'secondaryOutcomes': [{'measure': 'Measurement of oxidative and inflammatory markers', 'timeFrame': '2 weeks and 4 weeks', 'description': '2 weeks and 4 weeks treatment of oxidative markers such as reactive oxygen species, nitric oxide, glutathione peroxidase, and inflammatory cytokines such as tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, IL-6, and IL-10, etc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Inflammation', 'Skin Melanoma']}, 'descriptionModule': {'briefSummary': 'Vitamin D regulates various physiological functions, including calcium homeostasis, bone health, and potentially reducing cancer risks. Its primary source is Ultraviolet B radiation, but factors like aging, skin type, and modern lifestyles limit sun exposure, leading to widespread deficiency. This study explores using a daily Ultraviolet B Light Emitting Diodes device to improve vitamin D levels while assessing the potential for skin inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge ranges 19-65 years Healthy participants Patients who are willing or able to follow the doctor's instructions Fully understand the purpose and procedure of this clinical trial\n\nExclusion Criteria:\n\nParticipants excluded those who have any kind of disease Lactating and pregnant women Physical disabilities that could interfere with participation, a history of depression, or other psychiatric conditions"}, 'identificationModule': {'nctId': 'NCT06625918', 'briefTitle': 'Effects of Ultraviolet B Exposure Using a Ultraviolet Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'An Investigator-led Clinical Trial to Study the Effects of Ultraviolet Exposure Using a Ultraviolet B Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults', 'orgStudyIdInfo': {'id': 'EMB-2023-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'Single group\n\nTreatment', 'interventionNames': ['Device: Ultraviolet B exposure to produce vitamin D synthesis']}], 'interventions': [{'name': 'Ultraviolet B exposure to produce vitamin D synthesis', 'type': 'DEVICE', 'description': 'Exposure using a UV skin care device on vitamin D production and immune response in healthy adults', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Gwando', 'country': 'South Korea', 'facility': 'Prof. Kyu-Jae Lee, Ph.D.', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Kyu Jae Lee', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}