Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-01 @ 2:44 AM
Study NCT ID:
NCT05276661
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2022-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Project to Study Probiotic Beauty Products on Skin Improvement
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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of the TAC/Collagen Gel on Human Skin Hydration', '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': 'Effects of the TAC/Collagen Gel on Human Skin Sebum', 'timeFrame': 'Subjects will be tested in the 4th week', 'description': 'Callegari 1930 was utilized to measure skin inflammation. Units: arbitrary units.'}, {'measure': 'Effects of the TAC/Collagen gel on Human Skin Inflammation', 'timeFrame': 'Subjects will be tested in the 4th week', 'description': 'Chroma Meter MM-500 was utilized to measure skin inflammation. Units: arbitrary units.'}, {'measure': 'Effect of TAC/Collagen Gel on Human Acne Healing and Porphyrins Numbers', 'timeFrame': 'Subjects will be tested in the 4th week', 'description': 'VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units'}, {'measure': 'Effects of the TAC/Collagen Gel on Human Skin Brown Spot Numbers', 'timeFrame': 'Subjects will be tested in the 4th week', 'description': 'VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to use probiotic beauty products for 4 weeks and evaluate the impact of products on healthy skin.', 'detailedDescription': 'Twenty subjects were recruited and informed to apply the lotion gel twice per day (3\\~5 mg/cm2 once) for 4 weeks. Two kinds of facial lotiongels, "A" gel and "B" gel, were provided to every subject. The "A" gel (TAC/Collagen lotiongel) was applied on subjects\' right face and the "B" gel (placebo lotion) on their left face (formula showed as Table S2). Ordinary cosmetics usage was permitted but any change of usage was not allowed during the intervention. Outdoor activities (sun exposure) and the usage of sunscreen lotion were not limited in this study. Every subject was required to inspect his/her skin condition on week 0 and 4. Before inspection, the face was washed with water and waited for 30 min in an air-conditioned room (25°C, humility 55 ± 5%). Among these 20 subjects, eight of them had severe acne with at least two acne lesions on each side of face when participating this trial. They were instructed for more visits to evaluate the symptom of acne on week 1 and 2.\n\nSkin hydration (Corneometer CM825, Courage + Khazaka Electroni, Germany), sebum (Callegari 1930, Italy), and inflammation detection (Chroma Meter MM-500, Minolta, Japan) of upper cheek were measured in every subject. The improvement in inflammation was positively correlated with a decrease of a\\* value or an increase of L\\* value. VISIA® Complexion Analysis (VISIA® Complexion Analysis, U.S.A.) was also employed to measure the skin inflammation, porphyrins numbers and brown spot numbers of whole face. The result was presented as the mean value and the relative percentage (%) to the baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy volunteers aged above 20 years old\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. Involuntary subject\n6. People who is taking chronic disease medication'}, 'identificationModule': {'nctId': 'NCT05276661', 'briefTitle': 'A Project to Study Probiotic Beauty Products on Skin Improvement', 'organization': {'class': 'OTHER', 'fullName': 'Chia Nan University of Pharmacy ＆ Science'}, 'officialTitle': 'Chia Nan University of Pharmacy & Science', 'orgStudyIdInfo': {'id': 'TSMHIRB-2-R-025-2.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"A" gel (TAC/Collagen gel)', 'description': 'The "A" gel (TAC/Collagen gel) was applied on subjects\' right face', 'interventionNames': ['Dietary Supplement: TAC/Collagen gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': '"B" gel (placebo lotion)', 'description': 'the "B" gel (placebo lotion) on their left face', 'interventionNames': ['Dietary Supplement: placebo lotion']}], 'interventions': [{'name': 'TAC/Collagen gel', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Apply it twice per day for 4 weeks', 'armGroupLabels': ['"A" gel (TAC/Collagen gel)']}, {'name': 'placebo lotion', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Apply it twice per day for 4 weeks', 'armGroupLabels': ['"B" gel (placebo lotion)']}]}, '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, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chia Nan University of Pharmacy ＆ Scienc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Nan University of Pharmacy ＆ Science', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glac Biotech Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}