Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-30 @ 4:15 AM
Study NCT ID:
NCT06237959
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2024-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-01', 'size': 196488, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-24T23:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-01-24', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of hair elasticity', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in hair elasticity between the Keranat™ and placebo group.\n\nHair elasticity was measured using an Expert 7601Tension Testing System.'}, {'measure': 'The change of hair gloss', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in hair gloss between the Keranat™ and placebo group. Hair gloss was measured using a Skin-Glossy meter GL200.'}], 'secondaryOutcomes': [{'measure': 'The change of hair thickness', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in hair thickness improvement between the Keranat™ and placebo group. Hair thinness was assessed by measuring hair diameter using a microscope and ToupLite software.'}, {'measure': 'The change of anagen hair ratio(%)', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in the ratio of anagen hair between the Keranat™ and placebo group. Changes in Hair growth that occurred in the hair removal area for 3 days were analyzed using the Image-Pro® 10 program.'}, {'measure': 'The change in hair loss amount', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in the number of hair loss between the Keranat™ and placebo group. Collected and counted the number of lost hair.'}, {'measure': 'The change of number of hair per unit area', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in the number of hairs per unit area between the Keranat™ and placebo group. The number of hairs per unit area of the hair removal area was counted using Folliscope PS.'}, {'measure': 'The change of hair distribution score through clinical photography', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in hair distribution score through clinical photography between the Keranat™ and placebo group before and after intake. This evaluates improvement and deterioration on a 7-point scale, with higher scores meaning improvement. By comparing photos before and after intake, if there is no change, 0 points, improvement is a maximum of 3 points, and worsening is a minimum of -3 points.'}, {'measure': 'Self-reported Hair health assessments', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in Hair health improvement between the Keranat™ and placebo group. The evaluation was conducted through Patient Report Outcome(PRO) using a standardized survey form. Survey allowing for participant-report changes in hair health as a result of intervention using a 7-point scale.'}, {'measure': 'The change of serum levels of cytokines (IL-1, TNF-α, PGE2)', 'timeFrame': 'Change of the week 24 from baseline', 'description': 'To evaluate the change in serum levels of cytokines through clinical photography between the Keranat™ and placebo group.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hair gloss', 'Hair elasticity', 'Hair strength', 'Hair thickness', 'Anagen hair', 'Number of hair loss'], 'conditions': ['Hair Damage']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily intake of Keranat™ for 24 weeks can promote the gloss and elasticity of hairs, improve their density and strength, and reduce hair loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 and 60\n* Hair gloss score of 3 or less and a hair damage score of less than 18 according to the visual evaluation classification method.\n* Willing to maintain the same hairstyle, hair color, hair length, and hair regimen throughout the study period.\n* Subject must be able to comprehend and voluntarily sign study procedures and consent forms.\n\nExclusion Criteria:\n\n* Those diagnosed with and receiving treatment for the alopecia within 3 months before screening(androgenetic alopecia, alopecia areata, Telogen effluvium, etc.)\n* Use of that may affect hair or hair loss symptoms treatment medicine, dietary supplements, or treatments containing herbal medicine ingredients within 3 months before screening.\n* Any active scalp or skin disease that may interfere with the study treatment and evaluations.\n* Pregnancy or breastfeeding or planning pregnancy\n* Case of abnormal values at creatinine (excess at the upper limit of the reference range)\n* Case of abnormal values at ALT or AST (2 times excess at the upper limit of the reference range)'}, 'identificationModule': {'nctId': 'NCT06237959', 'briefTitle': 'Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutracore'}, 'officialTitle': 'A 24-Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health', 'orgStudyIdInfo': {'id': 'NC07-NOVA-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Keranat™', 'description': 'Keranat™ capsule will be administered orally twice daily for 24 weeks.', 'interventionNames': ['Dietary Supplement: Keranat™']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule will be administered orally twice daily for 24 weeks.', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Keranat™', 'type': 'DIETARY_SUPPLEMENT', 'description': '300 mg/capsule(proso millet and wheat extract 600 mg/day)', 'armGroupLabels': ['Keranat™']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '300 mg/capsule(600 mg/day as placebo)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11234', 'city': 'Seongnam-si', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'KSRC Korean Skin Research Center', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutracore', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novarex', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}