Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-27 @ 7:38 AM
Study NCT ID:
NCT05680857
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2022-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2022-12-27', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in skin hydration from baseline and at Day 14 and Day 28 after consumption of a product.', 'timeFrame': 'Baseline, Day 14 and Day 28', 'description': 'Skin hydration will be assessed using JANUS III skin analyzer and comparison will be made with placebo group.'}, {'measure': 'Changes in skin elasticity from baseline and at Day 14 and Day 28 after consumption of a product.', 'timeFrame': 'Baseline, Day 14 and Day 28', 'description': 'Skin elasticity will be assessed using JANUS III skin analyzer comparison will be made with placebo group.'}, {'measure': 'Changes in skin wrinkles from baseline and at Day 14 and Day 28 after consumption of a product.', 'timeFrame': 'Baseline, Day 14 and Day 28', 'description': 'Skin wrinkles will be assessed using JANUS III skin analyzer comparison will be made with placebo group.'}, {'measure': 'Changes in skin tone from baseline and at Day 14 and Day 28 after consumption of a product.', 'timeFrame': 'Baseline, Day 14 and Day 28', 'description': 'Skin hydration will be assessed using JANUS III skin analyzer comparison will be made with placebo group.'}, {'measure': 'Adverse effect after consumption of product containing marine collagen peptide and coenzyme Q10.', 'timeFrame': '28 Days', 'description': 'Based on adverse effect occurrence on participants that occur during study period (28 days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a placebo-controlled study conducted to investigates the safety and efficacy of products containing marine collagen peptide and CoQ10 in enhancing skin rejuvenation of Malaysian women. The study duration is 28 days and the skin assessment will be carried out at baseline, Day 14 and Day 28.The main questions it aims to answer are:\n\n1. The effect of product on skin hydration of women in Malaysia.\n2. The effect of product on skin elasticity of women in Malaysia.\n3. The effect of product on skin wrinkle of women in Malaysia.\n4. The skin brightening effect of product on Malaysian women.\n5. To observe any adverse effect occurrence with the consumption of the product.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malaysian citizen\n* Women aged 35 - 45 years old\n* Willing to participate\n\nExclusion Criteria:\n\n* Women with skin diseases or any underlying diseases.\n* Pregnant, breastfeeding women or planned pregnancy during the study period\n* Allergy to collagen or other ingredients that may be found in the product.\n* Women who had any cosmetic procedures such as botox, laser and light treatment, facial surgery, and any procedures that may improve skin hydration, elasticity, wrinkles, and brightening of skin four weeks before the study.\n* Women who took any dietary supplements, functional foods, or medicines that could have the same or similar effects as the product evaluated in this study in the past three months.'}, 'identificationModule': {'nctId': 'NCT05680857', 'briefTitle': 'Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre'}, 'officialTitle': 'The Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation in Malaysian Women', 'orgStudyIdInfo': {'id': 'UMRAMREC005-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "The placebo group will receive a product in sachet form that doesn't have marine collagen peptide and Coenzyme Q10.", 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Product containing marine collagen peptide and Coenzyme Q10.', 'description': 'This group will receive the product containing marine collagen peptide from the fish origin and Coenzyme Q10 in sachet form.', 'interventionNames': ['Other: Product containing marine collagen peptide and Coenzyme Q10.']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': "Product doesn't have active ingredients i.e. marine collagen peptide and Coenzyme Q10.", 'armGroupLabels': ['Placebo']}, {'name': 'Product containing marine collagen peptide and Coenzyme Q10.', 'type': 'OTHER', 'description': 'Product containing marine collagen peptide and Coenzyme Q10.', 'armGroupLabels': ['Product containing marine collagen peptide and Coenzyme Q10.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47810', 'city': 'Petaling Jaya', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre', 'geoPoint': {'lat': 3.10726, 'lon': 101.60671}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}