Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-31 @ 3:46 AM
Study NCT ID:
NCT05789368
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Testing of VeCollal Products
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': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The change of liver function biomarkers (AST, ALT) of blood', 'timeFrame': 'Change from Baseline liver function biomarkers at 8 weeks', 'description': 'Fasting 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': 'Fasting venous blood was sampled to measure renal function biomarkers'}, {'measure': 'The change of fasting blood glucose', 'timeFrame': 'Change from Baseline blood glucose at 8 weeks', 'description': 'Fasting venous blood was sampled to measure blood glucose'}, {'measure': 'The change of blood lipid profiles (total cholesterol, triglyceride)', 'timeFrame': 'Change from Baseline blood lipid profiles at 8 weeks', 'description': 'Fasting venous blood was sampled to measure blood lipid profiles'}, {'measure': 'The change of self-assessment skin condition', 'timeFrame': 'Change from Baseline skin condition at 8 weeks', 'description': 'A self-assessment questionnaire was collected to evaluate skin condition'}], 'primaryOutcomes': [{'measure': 'The change of skin collagen density', 'timeFrame': 'Change from Baseline skin collagen density at 8 weeks', 'description': 'DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units'}, {'measure': 'The change of skin wrinkles', 'timeFrame': 'Change from Baseline skin wrinkles at 8 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units'}, {'measure': 'The change of skin texture', 'timeFrame': 'Change from Baseline skin texture at 8 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units'}, {'measure': 'The change of skin elasticity', 'timeFrame': 'Change from Baseline skin elasticity at 8 weeks', 'description': 'SoftPlus was utilized to measure skin elasticity. Units: arbitrary units'}], 'secondaryOutcomes': [{'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 units'}, {'measure': 'The change of skin L* value', 'timeFrame': 'Change from Baseline skin L* value at 8 weeks', 'description': 'Chroma Meter MM500 was utilized to measure skin L\\* value. Units: arbitrary units, 0-100'}, {'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 units'}, {'measure': 'The change of skin moisture', 'timeFrame': 'Change from Baseline skin moisture index at 8 weeks', 'description': 'Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120'}, {'measure': 'The change of transepidermal water loss (TEWL)', 'timeFrame': 'Change from Baseline skin TEWL at 8 weeks', 'description': 'Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²'}, {'measure': 'The change of skin pores', 'timeFrame': 'Change from Baseline skin pores at 8 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Condition']}, 'descriptionModule': {'briefSummary': 'To assess VeCollal formula on skin condition improvement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged above 20 years old\n\nExclusion Criteria:\n\n* Subject who is not willing to participate in this study.\n* Patients with diseases of the skin, liver, kidney.\n* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.\n* Female who is pregnant or nursing or planning to become pregnant during the course of the study.\n* Received facial laser therapy, chemical peeling or UV overexposure (\\> 3 hr/week) in the past 4 weeks.\n* Constant drug use\n* Students who are currently taking courses taught by the principal investigator of this trial.'}, 'identificationModule': {'nctId': 'NCT05789368', 'briefTitle': 'Efficacy Testing of VeCollal Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Efficacy Testing of VeCollal Products', 'orgStudyIdInfo': {'id': '22-112-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo sachet', 'description': 'consume 1 sachet per day', 'interventionNames': ['Dietary Supplement: Placebo sachet']}, {'type': 'EXPERIMENTAL', 'label': 'VeCollal sachet', 'description': 'consume 1 sachet per day', 'interventionNames': ['Dietary Supplement: VeCollal sachet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Collagen sachet', 'description': 'consume 1 sachet per day', 'interventionNames': ['Dietary Supplement: Collagen sachet']}], 'interventions': [{'name': 'Placebo sachet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 sachet per day', 'armGroupLabels': ['Placebo sachet']}, {'name': 'VeCollal sachet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 sachet per day', 'armGroupLabels': ['VeCollal sachet']}, {'name': 'Collagen sachet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 sachet per day', 'armGroupLabels': ['Collagen sachet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71710', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chia Nan University of Pharmacy ＆ Science', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Chia-Hua Liang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chia Nan University of Pharmacy ＆ Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}