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.
