Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-02-04 @ 3:20 AM
Study NCT ID:
NCT04825561
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2021-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of AD-208
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of Change in the total number of hairs', 'timeFrame': 'Baseline, Week 24', 'description': 'The amount of change in the total number of hairs in the unit area'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia']}, 'referencesModule': {'references': [{'pmid': '40736519', 'type': 'DERIVED', 'citation': 'Lee S, Kim JE, Lew BL, Huh CH, Kim J, Kwon O, Kim MB, Lee YW, Lee Y, Park J, Kim S, Kim DY, Choi GS, Kang H. Efficacy and Safety of Low-Dose (0.2 mg) Dutasteride for Male Androgenic Alopecia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial. Ann Dermatol. 2025 Aug;37(4):183-190. doi: 10.5021/ad.25.048.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of AD-208.', 'detailedDescription': 'The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged 18-50 years, inclusive\n* Patients who meet the appropriate criteria according to the classification of hair loss\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients with hair loss disorders other than androgenetic alopecia\n* Other exclusions applied'}, 'identificationModule': {'nctId': 'NCT04825561', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of AD-208', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AD-208 in Male Patients With Androgenetic Alopecia', 'orgStudyIdInfo': {'id': 'AD-208P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': 'AD-208 and Placebo of AD-2081', 'interventionNames': ['Drug: AD-208', 'Drug: placebo of AD-2081']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Placebo of AD-208 and Placebo of AD-2081', 'interventionNames': ['Drug: placebo of AD-208', 'Drug: placebo of AD-2081']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Comparator', 'description': 'Placebo of AD-208 and AD-2081', 'interventionNames': ['Drug: AD-2081', 'Drug: placebo of AD-208']}], 'interventions': [{'name': 'AD-208', 'type': 'DRUG', 'description': 'PO, Once daily(QD), 24weeks', 'armGroupLabels': ['Active Comparator']}, {'name': 'AD-2081', 'type': 'DRUG', 'description': 'PO, Once daily(QD), 24weeks', 'armGroupLabels': ['Experimental Comparator']}, {'name': 'placebo of AD-208', 'type': 'DRUG', 'description': 'PO, Once daily(QD), 24weeks', 'armGroupLabels': ['Experimental Comparator', 'Placebo Comparator']}, {'name': 'placebo of AD-2081', 'type': 'DRUG', 'description': 'PO, Once daily(QD), 24weeks', 'armGroupLabels': ['Active Comparator', 'Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}