Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-04 @ 1:59 PM
Study NCT ID:
NCT02280603
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2014-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
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': 'D008914', 'term': 'Minoxidil'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram', 'timeFrame': 'baseline and week 24'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram', 'timeFrame': 'Baseline and week 16'}, {'measure': 'Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram', 'timeFrame': 'Baseline, week 16,and week24'}, {'measure': 'Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram', 'timeFrame': 'Baseline, week 16, and week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia\n\nDesign : Randomized, double-blind, active-controlled study\n\nInvestigational Product : Finasteride, minoxidil'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2\n\nExclusion Criteria:\n\n* Evidence of hair loss other than androgenetic alopecia\n* Use of finasteride, dutasteride within previous 12 months\n* Use of minoxidil within previous 6 months\n* Use of androgenic or anti-androgenic agents within previous 6 months\n* Use of steroid agents for local application to scalp or systemic application within previous 1 month\n* History of hair transplantation, scalp reduction\n* Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris'}, 'identificationModule': {'nctId': 'NCT02280603', 'briefTitle': 'Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia', 'orgStudyIdInfo': {'id': 'DA4001_AGAP_POC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DA-4001C', 'description': 'DA-4001C is administered', 'interventionNames': ['Drug: DA-4001C']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5% minoxidil', 'description': '5% minoxidil is administered', 'interventionNames': ['Drug: 5% minoxidil']}], 'interventions': [{'name': 'DA-4001C', 'type': 'DRUG', 'description': '1ml by topical application twice a day', 'armGroupLabels': ['DA-4001C']}, {'name': '5% minoxidil', 'type': 'DRUG', 'otherNames': ['minoxyl'], 'description': '1ml by topical application twice a day', 'armGroupLabels': ['5% minoxidil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-709', 'city': 'Seoul', 'state': 'Dongdaemun-gu', 'country': 'South Korea', 'facility': 'Catholic Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hoon Kang, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The catholic univ. of korea, St.Paul's hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}