Treatment of Androgenic Alopecia in Males

The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

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.

• Androgenetic Alopecia
• Hair Loss
• Male Pattern Baldness

• Device: HairMax LaserComb
  Device application 3 times week (non-consecutive days), for 26 weeks
• Device: Control device
  Device is used 3 times a week on non-consecutive days

• Active Comparator: HairMax LaserComb 2009, 12 Beam
  Low Level Laser Medical Device 2009 with 12 laser beams
  Intervention: Device: HairMax LaserComb
• Active Comparator: HairMax LaserComb 2009 9 Beam
  Low Level Laser Mecial Device 2009 with 9 laser beams
  Intervention: Device: HairMax LaserComb
• Active Comparator: 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.
  Intervention: Device: Control device

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