Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 5:16 PM
Study NCT ID:
NCT05143034
Status:
COMPLETED
Last Update Posted:
2021-12-07
First Post:
2021-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Evaluation of the Efficacy of TCI66207 on the 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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-06', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of skin moisture', 'timeFrame': 'Subjects will be tested in the 4th week.', 'description': 'Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120'}, {'measure': 'The change of skin elasticity', 'timeFrame': 'Subjects will be tested in the 4th week.', 'description': 'Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curvesCorneometer® units 0-120'}, {'measure': 'The change of skin wrinkles', 'timeFrame': 'Subjects will be tested in the 4th week.', 'description': 'VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units'}, {'measure': 'The change of skin collagen density', 'timeFrame': 'Subjects will be tested in the 4th week.', '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 skin texture', 'timeFrame': 'Subjects will be tested in the 4th week.', 'description': 'VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units'}, {'measure': 'The change of skin pores', 'timeFrame': 'Subjects will be tested in the 4th week.', 'description': 'VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea live-face bacteria on the skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy volunteers aged above 20 years old\n2. Subject has dull skin.\n\nExclusion Criteria:\n\n1. .Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).\n2. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.\n3. Female who is pregnant or nursing or planning to become pregnant during the course of the study.\n4. Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.\n5. Subjects who have large spots (area \\>3 square centimeter) or abnormal acne.'}, 'identificationModule': {'nctId': 'NCT05143034', 'briefTitle': 'the Evaluation of the Efficacy of TCI66207 on the Skin.', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Evaluation of Skin Efficacy of TCI66207', 'orgStudyIdInfo': {'id': 'TSMH No.18-148-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCI66207 Essence', 'description': 'Essence', 'interventionNames': ['Dietary Supplement: TCI66207 Essence']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Essence', 'interventionNames': ['Dietary Supplement: Placebo Essence']}], 'interventions': [{'name': 'TCI66207 Essence', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.', 'armGroupLabels': ['TCI66207 Essence']}, {'name': 'Placebo Essence', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.', 'armGroupLabels': ['Placebo Essence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'state': 'Neipu Township', 'country': 'Taiwan', 'facility': 'Research & Design Center, TCI CO., Ltd', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chia-Hua Liang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chia Nan University of Pharmacy ＆ Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}