Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-02 @ 4:26 AM
Study NCT ID:
NCT01548066
Status:
COMPLETED
Last Update Posted:
2012-10-08
First Post:
2011-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-05', 'studyFirstSubmitDate': '2011-07-20', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'linear hair growth rate', 'timeFrame': '24th week', 'description': 'the average growth rate of hair shaft for 3 days'}], 'secondaryOutcomes': [{'measure': 'final hair density', 'timeFrame': '24th week', 'description': 'total count of hair in a 1cm-diametered circle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia', 'Male Pattern Baldness']}, 'descriptionModule': {'briefSummary': 'Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at low level through regulation by GSK-3, multifunctional serine/threonin kinase. After phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore, inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been studied yet.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 19 years \\~ 45 years\n* subjects with AGA (Hamilton\\&Norwood grad III\\~IV)\n* subjects who are able to be followed for next 24 weeks.\n\nExclusion Criteria:\n\n* subjects with severe medical problems including cardiovascular diseases, renal problems, and chronic metabolic disease\n* subjects with AGA treated with surgical methods (hair TPL)\n* subjects who has ever applied minoxidil in recent 3 months or has taken finasteride or dutasteride in recent 6 months.\n* subjects who took medicine which can affect the hair growth\n* subjects with alopecia other than AGA'}, 'identificationModule': {'nctId': 'NCT01548066', 'briefTitle': 'The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss', 'orgStudyIdInfo': {'id': 'VPA_hair'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium valproate', 'description': 'spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks', 'interventionNames': ['Drug: Valproic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks', 'interventionNames': ['Drug: Control placebo']}], 'interventions': [{'name': 'Valproic Acid', 'type': 'DRUG', 'description': 'spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks', 'armGroupLabels': ['Sodium valproate']}, {'name': 'Control placebo', 'type': 'DRUG', 'description': 'spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Dermatology, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Oh Sang Kwon, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National Univeristy Hospital'}, {'name': 'Seong Jin Jo, Fellow', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amorepacific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}