Study Results
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View full resultsBasic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2009-07-31
2010-08-31
Brief Summary
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Detailed Description
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The trial will involve approximately 75 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 non-consecutive days a week as directed per device for 26 weeks treatment duration.
Safety analysis will be assessed based on the reports of adverse events during study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HairMax LaserComb 2009, 12 Beam
Low Level Laser Medical Device 2009 with 12 laser beams
HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
HairMax LaserComb 2009 9 Beam
Low Level Laser Mecial Device 2009 with 9 laser beams
HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
Control device
The control device appears identical to the active device, but utilizes 9 LED lights instead of laser lights. The randomized devices are blinded to the study investigator and distributed in a blinded manner to the participants.
Control device
Device is used 3 times a week on non-consecutive days
Interventions
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HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
Control device
Device is used 3 times a week on non-consecutive days
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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Zoe Draelos, MD
Role: PRINCIPAL_INVESTIGATOR
High Point, NC
David Goldberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
Skin & Laser
Abe Marcadis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Palm Beach Research
Locations
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Abe Marcadis, M.D.
West Palm Beach, Florida, United States
David Goldberg, M.D.
Hackensack, New Jersey, United States
Zoe Draelos, M.D.
High Point, North Carolina, 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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9.12 2009-M-02
Identifier Type: -
Identifier Source: org_study_id
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