Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT05310994
Status:
COMPLETED
Last Update Posted:
2022-09-29
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Evaluation of Wasabi Leaf Extract on Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of skin melanin index', 'timeFrame': 'Change from Baseline skin melanin index at 8 weeks', 'description': 'Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)'}, {'measure': 'The change of skin erythema index', 'timeFrame': 'Change from Baseline skin erythema index at 8 weeks', 'description': 'Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary Mexameter® units (0-999)'}, {'measure': 'The change of skin sebum content', 'timeFrame': 'Change from Baseline skin sebum content at 8 weeks', 'description': 'Sebumeter® SM815 was utilized to measure skin sebum content. Units: Sebumeter® units from 0-350'}, {'measure': 'The change of transepidermal water loss', 'timeFrame': 'Change from Baseline TEWL at 8 weeks', 'description': 'Tewameter® TM300 was utilized to measure transepidermal water loss (TEWL). Units: TEWL-values lower than 70 g/hm²'}, {'measure': 'The change of L* (lightness) values', 'timeFrame': 'Change from Baseline L* value at 8 weeks', 'description': 'Spectrophotometer SCM-108 was utilized to measure skin L\\* value. Units: arbitrary units'}, {'measure': 'The change of a* (redness) values', 'timeFrame': 'Change from Baseline a* value at 8 weeks', 'description': 'Spectrophotometer SCM-108 was utilized to measure skin a\\* value. Units: arbitrary units'}, {'measure': 'The change of visible spots', 'timeFrame': 'Change from Baseline visible spots at 8 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units'}, {'measure': 'The change of skin red area', 'timeFrame': 'Change from Baseline skin red area at 8 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin red area. Units: arbitrary units'}, {'measure': 'The change of total antioxidant capacity of blood', 'timeFrame': 'Change from Baseline total antioxidant capacity at 8 weeks', 'description': 'Venous blood was sampled to measure total antioxidant capacity'}, {'measure': 'The change of Interleukin-6 of blood', 'timeFrame': 'Change from Baseline IL-6 at 8 weeks', 'description': 'Venous blood was sampled to measure IL-6'}, {'measure': 'The change of Interleukin-8 of blood', 'timeFrame': 'Change from Baseline IL-8 at 8 weeks', 'description': 'Venous blood was sampled to measure IL-8'}, {'measure': 'The change of Insulin-Like Growth Factor-1 of blood', 'timeFrame': 'Change from Baseline IGF-1 at 8 weeks', 'description': 'Venous blood was sampled to measure IGF-1'}], 'secondaryOutcomes': [{'measure': 'The change of skin hydration', 'timeFrame': 'Change from Baseline skin hydration at 8 weeks', 'description': 'Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary'}, {'measure': 'The change of UV spots', 'timeFrame': 'Change from Baseline UV spots at 8 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure UV spots. Units: arbitrary units'}, {'measure': 'The change of brown spots', 'timeFrame': 'Change from Baseline brown spots at 8 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure brown spots. Units: arbitrary units'}, {'measure': 'The change of Advanced glycation end products of blood', 'timeFrame': 'Change from Baseline AGEs at 8 weeks', 'description': 'Venous blood was sampled to measure AGEs'}, {'measure': 'The change of liver function biomarkers (AST, ALT) of blood', 'timeFrame': 'Change from Baseline liver function biomarkers at 8 weeks', 'description': 'Venous blood was sampled to measure liver function biomarkers'}, {'measure': 'The change of renal function biomarkers (creatinine, BUN) of blood', 'timeFrame': 'Change from Baseline renal function biomarkers at 8 weeks', 'description': 'Venous blood was sampled to measure renal function biomarkers'}, {'measure': 'The change of fasting blood glugose level', 'timeFrame': 'Change from Baseline fasting blood glugose level at 8 weeks', 'description': 'Venous blood was sampled to measure fasting blood glugose level'}, {'measure': 'The change of blood lipid profile', 'timeFrame': 'Change from Baseline blood lipid profile at 8 weeks', 'description': 'Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Condition']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of Wasabi Leaf Extract on skin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 20 to 65-year-old males or females\n* People with dull skin, pigmentation spots or acne-prone, acne scars\n* Acne severity assessment- Investigator's Global Assessment Scale (IGA) ≥ 2\n\nExclusion Criteria:\n\n* Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial\n* Outdoor workers (exposed to the sun more than 5 hours a day)\n* People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report)\n* People with heart, liver, kidney, endocrine and other major organic diseases (self-reported)\n* People who have undergone major surgery (according to medical history)\n* People who take drugs for a long time\n* People with mental illness\n* Students who are currently taking courses taught by the principal investigator of this trial"}, 'identificationModule': {'nctId': 'NCT05310994', 'briefTitle': 'Efficacy Evaluation of Wasabi Leaf Extract on Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf Extract on Skin', 'orgStudyIdInfo': {'id': 'CMUH111-REC3-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'interventionNames': ['Dietary Supplement: Placebo drink']}, {'type': 'EXPERIMENTAL', 'label': 'Wasabi Leaf Extract Drink', 'interventionNames': ['Dietary Supplement: Wasabi Leaf Extract Drink']}], 'interventions': [{'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle per day', 'armGroupLabels': ['Placebo drink']}, {'name': 'Wasabi Leaf Extract Drink', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Wasabi (Wasabia japonica) leaf extract drink'], 'description': 'consume 1 bottle per day', 'armGroupLabels': ['Wasabi Leaf Extract Drink']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Hsiu-Mei Chiang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, China'}, {'name': 'Po-Yuan Wu, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'China Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}