Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-31 @ 10:37 PM
Study NCT ID:
NCT04266405
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Testing of Collagen and Zhuyin Drinks
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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-11', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of skin moisture', 'timeFrame': 'Change from Baseline skin moisture at 4 weeks', 'description': 'Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120'}, {'measure': 'The change of skin wrinkles', 'timeFrame': 'Change from Baseline skin wrinkles at 4 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units'}, {'measure': 'The change of skin collagen density', 'timeFrame': 'Change from Baseline skin collagen density at 4 weeks', 'description': 'DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:Intensity score'}, {'measure': 'The change of TEWL', 'timeFrame': 'Change from Baseline TEWL at 4 weeks', 'description': 'Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2'}, {'measure': 'The change of skin brightness', 'timeFrame': 'Change from Baseline skin brightness at 4 weeks', 'description': 'Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units'}, {'measure': 'The change of interleukin-6', 'timeFrame': 'Change from Baseline skin brightness at 4 weeks', 'description': 'Venous blood was sampled to measure concentrations of interleukin-6.'}, {'measure': 'The change of interleukin-8', 'timeFrame': 'Change from Baseline skin brightness at 4 weeks', 'description': 'Venous blood was sampled to measure concentrations of interleukin-8.'}, {'measure': 'The change of Tumor necrosis factor', 'timeFrame': 'Change from Baseline skin brightness at 4 weeks', 'description': 'Venous blood was sampled to measure concentrations of Tumor necrosis factor.'}, {'measure': 'The change of Matrix metalloproteinase-1', 'timeFrame': 'Change from Baseline skin brightness at 4 weeks', 'description': 'Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 .'}, {'measure': 'The change of metallopeptidase inhibitor 1', 'timeFrame': 'Change from Baseline skin brightness at 4 weeks', 'description': 'Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1.'}], 'secondaryOutcomes': [{'measure': 'The change of skin texture', 'timeFrame': 'Change from Baseline skin texture at 4 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units'}, {'measure': 'The change of skin pores', 'timeFrame': 'Change from Baseline skin pores at 4 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units'}, {'measure': 'The change of skin spots', 'timeFrame': 'Change from Baseline skin spots at 4 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units'}, {'measure': 'The change of red areas', 'timeFrame': 'Change from Baseline red areas at 4 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure red areas. Units: arbitrary units'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Condition']}, 'descriptionModule': {'briefSummary': 'To assess collagen and zhuyin drink on skin \\& body condition improvement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', '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, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).\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 in the past 4 weeks.\n* Vegetarian\n* Subjects who have large spots (area \\>3 square centimeter) or abnormal acne.'}, 'identificationModule': {'nctId': 'NCT04266405', 'briefTitle': 'Efficacy Testing of Collagen and Zhuyin Drinks', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Efficacy Testing of Collagen and Zhuyin Drinks', 'orgStudyIdInfo': {'id': '20-003-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'interventionNames': ['Dietary Supplement: Placebo drink']}, {'type': 'EXPERIMENTAL', 'label': 'Collagen and Zhuyin Drinks', 'interventionNames': ['Dietary Supplement: Collagen Cubilose Drink']}], 'interventions': [{'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle (50 mL) per day for 28 days', 'armGroupLabels': ['Placebo drink']}, {'name': 'Collagen Cubilose Drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle (50 mL) per day for 28 days', 'armGroupLabels': ['Collagen and Zhuyin Drinks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71710', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chia Nan University of Pharmacy ＆ Science', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}