Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT00981461
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2009-09-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Androgenetic Alopecia in Females, 9 Beam
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': '5614170200', 'title': 'David Michaels', 'organization': 'Lexington International, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Control Device', 'description': 'This control device is inactive emitting white light', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HairMax LaserComb 2009 9 Beam', 'description': 'This device is the active device with 9 laser modules', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Device', 'description': 'This control device is inactive emitting white light'}, {'id': 'OG001', 'title': 'HairMax LaserComb 2009 9 Beam', 'description': 'This device is the active device with 9 laser modules'}], 'classes': [{'title': 'Change at 16 weeks', 'categories': [{'measurements': [{'value': '1.3', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '9.70', 'groupId': 'OG001'}]}]}, {'title': 'Change at 26 weeks', 'categories': [{'measurements': [{'value': '2.8', 'spread': '16.48', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '11.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks, 26 weeks', 'description': 'The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.', 'unitOfMeasure': 'hairs per cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HairMax LaserComb 2009 9 Beam', 'description': 'This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.'}, {'id': 'FG001', 'title': 'Control Device', 'description': 'This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This double-blind, device controlled 26 week study was recruited at 6 clinical study sites. The recruitment period was from October 29, 2008 to March 2, 2009', 'preAssignmentDetails': 'Key exclusion criteria was pregnancy, malignancy in target area, an no hair transplants, scalp reductions, or hair weaves. Active hair loss less than 12 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HairMax LaserComb 2009 9 Beam', 'description': 'This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner'}, {'id': 'BG001', 'title': 'Control Device', 'description': 'This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis.'}, {'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': '43', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '65', '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': '43', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2009-09-21', 'resultsFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2009-09-21', 'lastUpdatePostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-21', 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline', 'timeFrame': 'Baseline, 16 weeks, 26 weeks', 'description': 'The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Andregenetic Alopecia', 'Hair Loss', 'Female Pattern Baldness'], 'conditions': ['Androgenetic Alopecia', 'Hair Loss', 'Female Pattern Baldness']}, 'referencesModule': {'references': [{'pmid': '19366270', 'type': 'RESULT', '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 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.', 'detailedDescription': 'This is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).\n\nThe trial with 60 female 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 Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.\n\nSubjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.\n\nInitial efficacy endpoint for each subject will be assess at visit 4 (week 16).\n\nSafety analysis will be assessed based on the reports of adverse events during study.'}, 'eligibilityModule': {'sex': 'FEMALE', '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* Ludwig I-4, II-1, II-2, or frontal\n* Active hair loss within last 12 months\n\nExclusion Criteria:\n\n* Photosensitivity to laser light\n* Malignancy in the target area\n* Pregnancy\n* Lactating females'}, 'identificationModule': {'nctId': 'NCT00981461', 'briefTitle': 'Treatment of Androgenetic Alopecia in Females, 9 Beam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexington International, LLC'}, 'officialTitle': 'A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females', 'orgStudyIdInfo': {'id': '151.0805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LLT Device 2009 9 Beam', 'description': 'HairMax LaserComb', 'interventionNames': ['Device: HairMax LaserComb']}, {'type': 'SHAM_COMPARATOR', 'label': 'control device', 'description': 'control device', 'interventionNames': ['Device: Control Device']}], 'interventions': [{'name': 'HairMax LaserComb', 'type': 'DEVICE', 'description': 'Device application 3 times week, for 26 weeks', 'armGroupLabels': ['LLT Device 2009 9 Beam']}, {'name': 'Control Device', 'type': 'DEVICE', 'description': 'Device application 3 times week, for 26 weeks', 'armGroupLabels': ['control device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jose Mendez, DO', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Abe Marcadis, MD', 'geoPoint': {'lat': 26.70562, 'lon': -80.03643}}, {'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'David Goldberg, MD', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Sadick Research Group', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Janet Hickman, MD', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], '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'}, {'name': 'David Goldberg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack, NJ'}, {'name': 'Neil S Sadick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sadick Research Group'}, {'name': 'Jose Mendez, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Dermatology Research, Inc.'}, {'name': 'Janet Hickman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Education and Researvh Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexington International, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}