Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 11:11 PM
Study NCT ID:
NCT06847035
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Oral Collagen Peptide on Skin Condition Improvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin firmness', 'timeFrame': 'before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)', 'description': 'The changes of skin firmness parameter tested by Cutometer MPA580'}, {'measure': 'Skin thickness', 'timeFrame': 'before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)', 'description': 'The changes of skin thickness （μm） tested by Ultrascan UC 22'}, {'measure': 'Skin density', 'timeFrame': 'before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)', 'description': 'The changes of skin density tested by Ultrascan UC 22'}], 'secondaryOutcomes': [{'measure': 'Skin hydration', 'timeFrame': 'before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)', 'description': 'The changes of skin hydration tested by Corneometer CM825'}, {'measure': 'Skin barrier', 'timeFrame': 'before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)', 'description': 'The changes of Trans Epidermal Water Loss (skin barrier parameter) tested by Tewameter TM300'}, {'measure': 'Facial image', 'timeFrame': 'before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)', 'description': 'Photo documents of left, right and frontal facial views'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Aging']}, 'referencesModule': {'references': [{'pmid': '41311286', 'type': 'DERIVED', 'citation': 'Wang Y, Zhu W, Luo W, Ma Y, Zhou Y. The Sustained Effects of Bioactive Collagen Peptides on Skin Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. J Cosmet Dermatol. 2025 Dec;24(12):e70565. doi: 10.1111/jocd.70565.'}]}, 'descriptionModule': {'briefSummary': 'To assess if oral intake of collagen peptide can improve skin conditions such as skin thickness, density and firmness.', 'detailedDescription': 'This is an one site, randomized, double-blind controlled clinical trial to assess the oral supplement of LISAVEI collagen peptide solid beverage on skin ageing improvement. Study product with collagen peptide and placebo product without collagen were randomly assigned to 90 eligible participants enrolled according to the inclusion and exclusion criteria. They took the assigned product once daily dissolved in 100 ml warm water for 12 weeks with 4-week regression phase(without intake of the test products), and visit the study site in Shanghai for four times(before starting the treatment, after 8 and 12 weeks, and 4 weeks after the last intake). Skin measurements including skin firmness, skin density, skin hydration and skin barrier were carried out at each visit with professional equipment and imaging system. Data were analyzed to validate if the administration of the test collagen peptide solid beverage will improve skin aging parameters such as firmness, thickness, density, hydration and skin barrier compared to placebo. The lasting effect was also observed by comparing between the two groups after 4-week regression time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy female adults aged between 35-55 years old\n2. With fine wrinkles and skin laxity\n3. Personal informed consents to participate in the study\n4. Agree to keep their daily skincare routine unchanged for the duration of the study\n5. Maintain good sun protection habits\n\n5\\. Agree to refrain from wearing make-up on the face on the each study visit\n\nExclusion Criteria\n\n1. Female who is pregnant or nursing or planning to become pregnant during the course of the study\n2. Individuals who are in the perimenopausal stage.\n3. BMI\\<18.5 or BMI \\>27.9\n4. Individuals suffering from chronic systemic diseases such as cardiovascular, cerebrovascular, liver, and kidney diseases.\n5. Individuals who have diabetes.\n6. Individuals suffering from skin conditions such as psoriasis, eczema, atopic dermatitis, and severe acne.\n7. Individuals with depression or sleep disorders, those who smoke, and those who abuse alcohol.\n8. Individuals who are using hormonal drugs, medications for obesity, absorption inhibitors, antidepressants, or appetite suppressants.\n9. Individuals who have used hormones or anti-inflammatory drugs on their face and upper arms within the past two months.\n10. Individuals who received facial laser therapy, chemical peeling or UV overexposure in the past 3 months\n11. Individuals who can not avoid prolonged exposure to sunlight.\n12. Individuals who are currently participating in other clinical studies or trials.'}, 'identificationModule': {'nctId': 'NCT06847035', 'briefTitle': 'Efficacy Study of Oral Collagen Peptide on Skin Condition Improvement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Meifute Biotechnology Co., Ltd'}, 'officialTitle': 'Efficacy Study of Oral Collagen Peptide on Skin Conditions', 'orgStudyIdInfo': {'id': 'YKEC-2024-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': 'collagen peptide solid beverage', 'interventionNames': ['Dietary Supplement: Active Comparator']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comaprator', 'description': 'placebo solid beverage', 'interventionNames': ['Dietary Supplement: Placebo Comparator']}], 'interventions': [{'name': 'Active Comparator', 'type': 'DIETARY_SUPPLEMENT', 'description': 'LISAVEI collagen peptide solid beverage ( contain 5 g collagen peptide)，once daily for 12 weeks', 'armGroupLabels': ['Active Comparator']}, {'name': 'Placebo Comparator', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['placebo solid beverage'], 'description': 'placebo solid beverage (Maltodextrin with edible flavor)，once daily for 12 weeks', 'armGroupLabels': ['Placebo Comaprator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '021', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Fumei Dermatology Clinic', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Meifute Biotechnology Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}