NCT00947505

Treatment of Androgenetic Alopecia in Males

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Lexington International, LLC · Industry
• Sex: Male
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Androgenetic Alopecia
• Hair Loss
• Male Pattern Baldness

Interventions

Type	Name	Description
DEVICE	HairMax LaserComb 2009, 7 Beam	Device application 3 times week (non-consecutive days), for 26 weeks
DEVICE	HairMax LaserComb	Device application 3 times week (non-consecutive days), for 26 weeks

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-07-28
• Last updated: 2012-07-30
• Results posted: 2012-07-30

Locations

2 sites across 1 country: United States