Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04237818
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2020-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
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': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-27', 'studyFirstSubmitDate': '2020-01-19', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of skin moisture', 'timeFrame': 'Change from Baseline skin moisture at 8 weeks', 'description': 'Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120'}, {'measure': 'The change of skin elasticity', 'timeFrame': 'Change from Baseline skin elasticity at 8 weeks', 'description': 'Cutometer® dual MPA 580 is utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves'}, {'measure': 'The change of skin wrinkles', 'timeFrame': 'Change from Baseline skin wrinkles at 8 weeks', 'description': '3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units'}, {'measure': 'The change of skin collagen density', 'timeFrame': 'Change from Baseline skin collagen density at 8 weeks', 'description': 'DermaLab® combo - 20 MHz High Freq. Ultrasound probe is utilized to scan and analyze skin collagen density. Units: Intensity score'}, {'measure': 'The change of skin tone', 'timeFrame': 'Change from Baseline skin tone at 8 weeks', 'description': '3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units'}, {'measure': 'The change of skin brightness', 'timeFrame': 'Change from Baseline skin brightness at 8 weeks', 'description': '3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units'}, {'measure': 'The change of skin melanin index', 'timeFrame': 'Change from Baseline skin melanin index at 8 weeks', 'description': 'Mexameter® MX 18 is utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)'}, {'measure': 'The change of skin L*a*b* value', 'timeFrame': 'Change from Baseline skin L*a*b* value at 8 weeks', 'description': 'Color Spectrophotometer SCM-104/108 is utilized to measure skin L\\*a\\*b\\* value. Units: arbitrary units'}], 'secondaryOutcomes': [{'measure': 'The change of transepidermal water loss (TEWL)', 'timeFrame': 'Change from Baseline TEWL at 8 weeks', 'description': 'Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm²'}, {'measure': 'The change of skin texture', 'timeFrame': 'Change from Baseline skin texture at 8 weeks', 'description': '3D Full-Face Skin Analyzer IRV is utilized to measure skin texture. Units: arbitrary units'}, {'measure': 'The change of skin pores', 'timeFrame': 'Change from Baseline skin pores at 8 weeks', 'description': '3D Full-Face Skin Analyzer IRV is utilized to measure skin pores. Units: arbitrary units'}, {'measure': 'The change of skin spots', 'timeFrame': 'Change from Baseline skin spots at 8 weeks', 'description': '3D Full-Face Skin Analyzer IRV is utilized to measure skin spots. Units: arbitrary units'}, {'measure': 'The change of skin erythema level', 'timeFrame': 'Change from Baseline skin erythema level at 8 weeks', 'description': 'Mexameter® MX 18 is utilized to measure skin erythema level. Units: arbitrary Mexameter® units (0-999)'}, {'measure': 'Self-assessment questionnaire', 'timeFrame': '8 weeks', 'description': 'Questionnaire is utilized to assess skin condition of the subjects. Units: score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Condition']}, 'descriptionModule': {'briefSummary': 'To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged between 20-65 years old\n* Subjects must read and sign the informed consent form after the study has been fully explained.\n* Subjects are willing to cooperate and comply with all of the regulation during the trial.\n* Subject should inform to investigator immediately if adverse effect is happened.\n* Subjects are willing to avoid UV overexposure during the trial (include indoor tanning treatment).\n\nExclusion Criteria:\n\n* Subjects who have known cosmetic, drug or food allergies.\n* Subjects who have severe desquamation, tattoo, sunburn, peeling skin or other skin condition might impact measurement.\n* Subjects with any physical condition judged by the researcher not to be eligible for this study.\n* Subjects with uncontrollable physical condition such as high blood pressure, thyroid disease, diabetes, etc.\n* Female who is pregnant or nursing or planning to become pregnant during the course of the study.\n* Those who are currently participating in other clinical trials or who have just concluded a clinical trial two weeks ago.\n* Women who have started contraceptive or change current hormone contraceptive methods within 3 months.'}, 'identificationModule': {'nctId': 'NCT04237818', 'briefTitle': 'The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect', 'orgStudyIdInfo': {'id': 'CMUH108-REC1-147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'interventionNames': ['Dietary Supplement: Placebo drink']}, {'type': 'EXPERIMENTAL', 'label': 'Chenopodium Formosanum and Fagopyrum Esculentum Extract drink', 'interventionNames': ['Dietary Supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink']}], 'interventions': [{'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 2 bottle (30 mL) per day for 56 days', 'armGroupLabels': ['Placebo drink']}, {'name': 'Chenopodium Formosanum and Fagopyrum Esculentum Extract drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 2 bottle (30 mL) per day for 56 days', 'armGroupLabels': ['Chenopodium Formosanum and Fagopyrum Esculentum Extract drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', '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'}}}}