Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05311020
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2022-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Evaluation of Pitaya Ovule Extract on 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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of L* (lightness) values', 'timeFrame': 'Change from Baseline L* value at 8 weeks', 'description': 'Spectrophotometer SCM-108 was utilized to measure skin L\\* value. Units: arbitrary units'}, {'measure': 'The change of skin elasticity', 'timeFrame': 'Change from Baseline skin elasticity at 8 weeks', 'description': 'Cutometer® Dual MPA580 was utilized to measure skin elasticity. Units: arbitrary units'}, {'measure': 'The change of skin collagen density', 'timeFrame': 'Change from Baseline skin collagen density at 8 weeks', 'description': 'DermaLab® Combo Ultrasound module was utilized to measure skin collagen density. Units: arbitrary units'}, {'measure': 'The change of skin wrinkles', 'timeFrame': 'Change from Baseline skin wrinkles at 8 weeks', 'description': 'IRV skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units'}, {'measure': 'The change of skin texture', 'timeFrame': 'Change from Baseline skin texture at 8 weeks', 'description': 'IRV skin analyzer was utilized to measure skin texture. Units: arbitrary units'}, {'measure': 'The change of skin pores', 'timeFrame': 'Change from Baseline skin pores at 8 weeks', 'description': 'IRV skin analyzer was utilized to measure skin pores. Units: arbitrary units'}, {'measure': 'The change of skin tone', 'timeFrame': 'Change from Baseline skin tone at 8 weeks', 'description': 'IRV skin analyzer was utilized to measure skin tone. Units: arbitrary units'}, {'measure': 'The change of Advanced glycation end products of blood', 'timeFrame': 'Change from Baseline AGEs at 8 weeks', 'description': 'Venous blood was sampled to measure AGEs'}, {'measure': 'The change of RAGE (receptor for advanced glycation end products) of blood', 'timeFrame': 'Change from Baseline RAGE at 8 weeks', 'description': 'Venous blood was sampled to measure RAGE'}, {'measure': 'The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood', 'timeFrame': 'Change from Baseline MMPs at 8 weeks', 'description': 'Venous blood was sampled to measure MMPs'}], 'secondaryOutcomes': [{'measure': 'The change of liver function biomarkers (AST, ALT) of blood', 'timeFrame': 'Change from Baseline liver function biomarkers at 8 weeks', 'description': 'Venous blood was sampled to measure liver function biomarkers'}, {'measure': 'The change of renal function biomarkers (creatinine, BUN) of blood', 'timeFrame': 'Change from Baseline renal function biomarkers at 8 weeks', 'description': 'Venous blood was sampled to measure renal function biomarkers'}, {'measure': 'The change of fasting blood glucose level', 'timeFrame': 'Change from Baseline fasting blood glucose level at 8 weeks', 'description': 'Venous blood was sampled to measure fasting blood glucose level'}, {'measure': 'Change from Baseline insulin level at 8 weeks', 'timeFrame': 'Change from Baseline insulin level at 8 weeks', 'description': 'Venous blood was sampled to measure insulin level'}, {'measure': 'The change of blood lipid profile', 'timeFrame': 'Change from Baseline blood lipid profile at 8 weeks', 'description': 'Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Condition']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of Pitaya Ovule Extract on skin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 to 65-year-old males or females\n\nExclusion Criteria:\n\n* Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial\n* Outdoor workers (exposed to the sun more than 5 hours a day)\n* People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report)\n* People with heart, liver, kidney, endocrine and other major organic diseases (self-reported)\n* People who have undergone major surgery (according to medical history)\n* People who take drugs for a long time\n* People with mental illness\n* Students who are currently taking courses taught by the principal investigator of this trial'}, 'identificationModule': {'nctId': 'NCT05311020', 'briefTitle': 'Efficacy Evaluation of Pitaya Ovule Extract on Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Efficacy Evaluation of Pitaya Ovule Extract on Skin', 'orgStudyIdInfo': {'id': 'CMUH111-REC3-028-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'interventionNames': ['Dietary Supplement: Placebo drink']}, {'type': 'EXPERIMENTAL', 'label': 'Pitaya Ovule Extract Drink', 'interventionNames': ['Dietary Supplement: Pitaya Ovule Extract Drink']}], 'interventions': [{'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle per day', 'armGroupLabels': ['Placebo drink']}, {'name': 'Pitaya Ovule Extract Drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle per day', 'armGroupLabels': ['Pitaya Ovule Extract Drink']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Hsiu-Mei Chiang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, China'}, {'name': 'Po-Yuan Wu, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'China Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}