Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2009-08-31
2010-08-31
Brief Summary
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Detailed Description
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The 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.
Subjects will use the device on three nonconcurring days a week as directed per device for 26 weeks treatment duration.
Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HairMax LaserComb 2009, 7 Beam
Lower level laser phototherapy medical device with 7 laser beams
HairMax LaserComb 2009, 7 Beam
Device application 3 times week (non-consecutive days), for 26 weeks
Control Device
Identical to the Active device, but with 7 LED's instead of lasers
HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
Interventions
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HairMax LaserComb 2009, 7 Beam
Device application 3 times week (non-consecutive days), for 26 weeks
HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fitzpatrick Skin Types I-IV
* Norwood-Hamilton IIa to V
* Active hair loss within last 12 months
Exclusion Criteria
* Malignancy in the target area
25 Years
60 Years
MALE
Yes
Sponsors
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Lexington International, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Jarratt, M.D.
Role: PRINCIPAL_INVESTIGATOR
DermaResearch, Inc.
Abe Marcadis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Palm Beach Research Center
Locations
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Abe Marcadis, M.D.
Palm Beach, Florida, United States
Michael Jarratt, MD
Austin, Texas, United States
Countries
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References
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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.
Other Identifiers
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7 2009-M-01
Identifier Type: -
Identifier Source: org_study_id