Brief Title
Treatment of Androgenetic Alopecia in Males
Official Title
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
Brief Summary
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.
Detailed Description
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). 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.
Study Type
Interventional
Primary Outcome
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline
Condition
Androgenetic Alopecia
Intervention
HairMax LaserComb 2009, 7 Beam
Study Arms / Comparison Groups
HairMax LaserComb 2009, 7 Beam
Description: Lower level laser phototherapy medical device with 7 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
49
Start Date
August 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
Michael Jarratt, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00947505
Organization ID
7 2009-M-01
Responsible Party
Sponsor
Study Sponsor
Lexington International, LLC
Study Sponsor
Michael Jarratt, M.D., Principal Investigator, DermaResearch, Inc.
Verification Date
June 2012