Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06306105
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Anti-aging Efficacy of Marine Collagen Peptides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D009263', 'term': 'Nails, Ingrown'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009260', 'term': 'Nail Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of skin hydation', 'timeFrame': 'Change from Baseline skin skin hydation at 12 weeks', 'description': 'Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation. Units: arbitrary Corneometer® units 0-120.'}, {'measure': 'The change of skin wrinkles', 'timeFrame': 'Change from Baseline skin wrinkles at 12 weeks', 'description': 'VISIA Complexion Analysis was utilized to measure skin wrinkles. Units: the amount of detectable wrinkles'}, {'measure': 'The change of skin elasticity', 'timeFrame': 'Change from Baseline skin elasticity at 12 weeks', 'description': 'Cutometer® MPA580 was utilized to measure skin elasticity. Units: visco-elasticity in %.'}, {'measure': 'The change of skin collagen density', 'timeFrame': 'Change from Baseline skin collagen density at 12 weeks', 'description': 'DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units'}, {'measure': 'The change of hair diameters', 'timeFrame': 'Change from Baseline hair diameters at 12 weeks', 'description': 'Mitutoyo C/N293-100 was utilized to measure hair diameters. Units: millimeter'}, {'measure': 'The change of hair loss amount', 'timeFrame': 'Change from Baseline hair loss amount at 12 weeks', 'description': 'Collect and measure the weight of loss hair. Units: gram'}, {'measure': 'The change of hair roots diameters', 'timeFrame': 'Change from Baseline hair roots diameters at 12 weeks', 'description': 'Mitutoyo C/N293-100 was utilized to measure hair roots diameters. Units: millimeter'}, {'measure': 'The change of hair density', 'timeFrame': 'Change from Baseline hair density at 12 weeks', 'description': 'Soft Plus was utilized to picture and observe hair density.'}, {'measure': 'The change of hair follicle strength', 'timeFrame': 'Change from Baseline hair follicle strength at 12 weeks', 'description': 'Pull up the hair of the frontal bone, temporal bone and occipital bone (approximately 60 hairs/area) to assess the number of hair loss in each area. Units: the number of loss hair'}, {'measure': 'The change of thumbs nail color', 'timeFrame': 'Change from Baseline thumbs nail color at 12 weeks', 'description': 'Chroma Meter MM500 was utilized to measure thumbs nail color. Units: L\\* index'}, {'measure': 'The change of nails appearence', 'timeFrame': 'Change from Baseline nails appearence at 12 weeks', 'description': 'Picture taken was utilized to record and observe nails appearence.'}, {'measure': 'The change of nails growth', 'timeFrame': 'Change from Baseline marking position at 12 weeks', 'description': 'Marking the position of middle fingers lunula was utilized to record and observe nails growth. Units: milimeter'}, {'measure': 'The degree of nails fragility', 'timeFrame': 'Change from Baseline nails fragility at 12 weeks', 'description': 'Iron ruler was utilized to evaluate nails fragility. Picture taken was utilized to record and observe the change of nails fragility.'}], 'secondaryOutcomes': [{'measure': 'The change of self-assessment skin, hair, and nails condition', 'timeFrame': 'Change from Baseline skin, hair, and nails condition at 12 weeks', 'description': 'A self-assessment questionnaire was collected and evaluate skin, hair, and nails condition'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fish collagen'], 'conditions': ['Skin Condition', 'Hair Fragility', 'Nails, Ingrown']}, 'descriptionModule': {'briefSummary': 'To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged above 18 years old\n\nExclusion Criteria:\n\n* Subjects who are not volunteers\n* Subjects who have been diagnosed with dermatitis, cirrhosis, and chronic kidney failure\n* Subjects who have known cosmetic, drug or food allergies.\n* Patients are taking medicine for chronic diseases\n* Subjects receiving treatments for scalp, hair transplant, and other scalp medical care in past 12 weeks.\n* Subjects getting a manicure and perm in past 12 weeks.\n* Female who is pregnant or nursing or planning to become pregnant during the course of the study.\n* Subjects receiving facial laser therapy, chemical peeling or UV overexposure (\\> 3 hr/week) in the past 12 weeks.\n* Students who are currently taking courses taught by the principal investigator of this trial.\n* Subjects are not willing to reveal the results of pictures after taking the product\n* Vegetarian.'}, 'identificationModule': {'nctId': 'NCT06306105', 'briefTitle': 'Assessment of Anti-aging Efficacy of Marine Collagen Peptides', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Assessment of Anti-aging Efficacy of Marine Collagen Peptides', 'orgStudyIdInfo': {'id': '23-118-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo drink', 'interventionNames': ['Dietary Supplement: placebo drink']}, {'type': 'EXPERIMENTAL', 'label': 'Marine Collagen Peptides drinks', 'interventionNames': ['Dietary Supplement: Marine Collagen Peptides']}], 'interventions': [{'name': 'Marine Collagen Peptides', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Coral club Promarine Collagen Tripeptides'], 'description': 'consume 1 bottle per day', 'armGroupLabels': ['Marine Collagen Peptides drinks']}, {'name': 'placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle per day', 'armGroupLabels': ['placebo drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '928', 'city': 'Pingtung City', 'country': 'Taiwan', 'facility': 'Chia Nan University of Pharmacy & Science', 'geoPoint': {'lat': 22.67135, 'lon': 120.48814}}], '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'}}}}