Brief Title
Treatment of Androgenic Alopecia in Males
Official Title
A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males
Brief Summary
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
Detailed Description
This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). 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.
Study Type
Interventional
Primary Outcome
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
Condition
Androgenetic Alopecia
Intervention
HairMax LaserComb
Study Arms / Comparison Groups
HairMax LaserComb 2009, 12 Beam
Description: Low Level Laser Medical Device 2009 with 12 laser beams
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
79
Start Date
July 2009
Completion Date
August 2010
Primary Completion Date
August 2010
Eligibility Criteria
Inclusion Criteria: - Diagnosis of androgenetic alopecia - Fitzpatrick Skin Types I-IV - Norwood-Hamilton IIa to V - Active hair loss within last 12 months Exclusion Criteria: - Photosensitivity to laser light - Malignancy in the target area
Gender
Male
Ages
25 Years - 60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Zoe Draelos, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00947219
Organization ID
9.12 2009-M-02
Responsible Party
Sponsor
Study Sponsor
Lexington International, LLC
Study Sponsor
Zoe Draelos, MD, Principal Investigator, High Point, NC
Verification Date
December 2012