Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00947505
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2009-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Androgenetic Alopecia in Males
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dm@hairmax.com', 'phone': '561-417-0200', 'title': 'David Michaels', 'organization': 'Lexington International, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LLT Device 2009 7 Beam', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Device', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LLT Device 2009 7 Beam', 'description': 'This is the active LLLT device'}, {'id': 'OG001', 'title': 'Control Device', 'description': 'This is the control device emitting white light'}], 'classes': [{'title': 'Change at 16 weeks', 'categories': [{'measurements': [{'value': '17.7', 'spread': '12.83', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '6.89', 'groupId': 'OG001'}]}]}, {'title': 'Change at 26 weeks', 'categories': [{'measurements': [{'value': '18.4', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '8.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 and 26 weeks', 'description': 'Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region', 'unitOfMeasure': 'change in terminal hair count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LLT Device 2009 7 Beam'}, {'id': 'FG001', 'title': 'Control Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-Iv, with Norwood Hamilton Classifications of IIa-V, have active hair loss with the last 12 months', 'preAssignmentDetails': 'Exclusion Criteria: Individuals with photosensitivity to laser light, histor of any malignancy in target area. Also, use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to baseline and use of retinoids in past year, chronic dermatological condtion (eczema , psoriasis, infection, etc.) of the scalp other than male pattern baldness'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LLT Device 2009 7 Beam'}, {'id': 'BG001', 'title': 'Control Device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2009-07-27', 'resultsFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2009-07-27', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-21', 'studyFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline', 'timeFrame': '16 and 26 weeks', 'description': 'Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Androgenetic alopecia', 'Hair loss', 'Male Pattern baldness'], 'conditions': ['Androgenetic Alopecia', 'Hair Loss', 'Male Pattern Baldness']}, 'referencesModule': {'references': [{'pmid': '19366270', 'type': 'BACKGROUND', 'citation': 'Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.', 'detailedDescription': 'This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).\n\nThe trial will involve 45 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.\n\nSubjects will use the device on three nonconcurring days a week as directed per device for 26 weeks treatment duration.\n\nInitial efficacy endpoint for each subject will be assessed at visit 4 (week 16).\n\nSafety analysis will be assessed based on the reports of adverse events during study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of androgenetic alopecia\n* Fitzpatrick Skin Types I-IV\n* Norwood-Hamilton IIa to V\n* Active hair loss within last 12 months\n\nExclusion Criteria:\n\n* Photosensitivity to laser light\n* Malignancy in the target area'}, 'identificationModule': {'nctId': 'NCT00947505', 'briefTitle': 'Treatment of Androgenetic Alopecia in Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexington International, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 7 Beam Model: For the Treatment of Androgenetic Alopecia in Males', 'orgStudyIdInfo': {'id': '7 2009-M-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HairMax LaserComb 2009, 7 Beam', 'description': 'Lower level laser phototherapy medical device with 7 laser beams', 'interventionNames': ['Device: HairMax LaserComb 2009, 7 Beam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Device', 'description': "Identical to the Active device, but with 7 LED's instead of lasers", 'interventionNames': ['Device: HairMax LaserComb']}], 'interventions': [{'name': 'HairMax LaserComb 2009, 7 Beam', 'type': 'DEVICE', 'otherNames': ['HairMax LaserComb'], 'description': 'Device application 3 times week (non-consecutive days), for 26 weeks', 'armGroupLabels': ['HairMax LaserComb 2009, 7 Beam']}, {'name': 'HairMax LaserComb', 'type': 'DEVICE', 'otherNames': ['Control device'], 'description': 'Device application 3 times week (non-consecutive days), for 26 weeks', 'armGroupLabels': ['Control Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33409', 'city': 'Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Abe Marcadis, M.D.', 'geoPoint': {'lat': 26.70562, 'lon': -80.03643}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael Jarratt, MD', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Michael Jarratt, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DermaResearch, Inc.'}, {'name': 'Abe Marcadis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Palm Beach Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexington International, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}