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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Device application 3 times week (non-consecutive days), for 26 weeks
Device application 3 times week (non-consecutive days), for 26 weeks
Abe Marcadis, M.D.
Palm Beach, Florida, United States
Michael Jarratt, MD
Austin, Texas, United States
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline
Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region
Time frame: 16 and 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.