Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-01 @ 9:45 AM
Study NCT ID:
NCT03350893
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Parallel, Open Label Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Diagnosis', 'timeFrame': 'Baseline, 4 weeks and 8 weeks', 'description': 'The changes of skin condition by VISIA Complexion Analysis System'}], 'secondaryOutcomes': [{'measure': 'Skin Moisture', 'timeFrame': 'Baseline, 4 weeks and 8 weeks', 'description': 'The changes of skin moisture by Skicon-200EX and Corneometer CM 825'}, {'measure': 'Skin Color', 'timeFrame': 'Baseline, 4 weeks and 8 weeks', 'description': 'The changes of skin color by DermaSpectrometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Problems']}, 'descriptionModule': {'briefSummary': 'Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus plantarum cream on skin health.', 'detailedDescription': 'To evaluate the efficacy of applying probiotic cream in the ameliorationof the whole face skin conditions such as moisturizing, whitening, anti-wrinkle and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers between the ages of 20-60.\n\nExclusion Criteria:\n\n* Subjects with photosensitivity (Sun allergy).\n* Subjects are undergoing medical therapy for skin diseases.\n* Subjects with severe hyperpigmentation.\n* Subjects with diabetes.\n* Subjects with cosmetics allergy.\n* Subjects who have recently participated laser therapies or other treatments are not suitable for sun.'}, 'identificationModule': {'nctId': 'NCT03350893', 'briefTitle': 'Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'GenMont Biotech Incorporation'}, 'officialTitle': 'Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin', 'orgStudyIdInfo': {'id': '17-047-A2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Emulsion base without probiotics', 'interventionNames': ['Other: Emulsion base']}, {'type': 'EXPERIMENTAL', 'label': 'Active Group', 'description': 'Emulsion base with probiotics', 'interventionNames': ['Combination Product: Emulsion base with probiotics']}], 'interventions': [{'name': 'Emulsion base with probiotics', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Active Group'], 'description': 'Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide, Heat-killed L. plantarum powders (1x10\\^9 cells/ g-cream)', 'armGroupLabels': ['Active Group']}, {'name': 'Emulsion base', 'type': 'OTHER', 'otherNames': ['Control Group'], 'description': 'Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71710', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chia Nan University of Pharmacy and Science', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Ching-Gong Lin, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chia Nan University of Pharmacy and Science, Taiwan, R.O.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GenMont Biotech Incorporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chia Nan University of Pharmacy and Science', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}