Latest Study Results of HairMax LaserComb's Safety and Effectiveness
HairMax LaserComb Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia: A Randomized, Double-Blind, Sham Device-Controlled, Multicentre Trial.
The use of low levels of visible or near-infrared light for reducing pain, inflammation and oedema, promoting the healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years, since the invention of lasers. The HairMax LaserComb is a hand-held, low level, laser therapy device that contains a single laser module that emits nine beams. The device parts the user's hair by combs that are attached to the device. This improves the delivery of the distributed laser light to the scalp. By parting the hair, the laser energy can be delivered to the scalp of the user without being obstructed by the individual hairs on the scalp.
The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia. This double-blind, placebo device-controlled, multicentre, 26-week trial randomly allocated male patients with Norwood-Hamilton classes IIa-V to treatment with the HairMax LaserComb or the placebo device. The placebo device used in the study was identical to the active device except that the laser light was replaced by a non-active incandescent light source. Of the 110 patients who completed the study, subjects in the HairMax LaserComb's treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the placebo device group. Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients' subjective assessments. No further details on those improvements were provided though. The HairMax LaserComb was well tolerated, with no serious adverse events reported and no statistical difference in adverse effects between the study groups.
The results of this study suggest that the HairMax LaserComb is an effective, well tolerated and safe laser phototherapy device for the treatment of androgenetic alopecia in males. This multicenter study was sponsored by Lexington International and approved by an Independent Review Board and complied with all Good Clinical Practice Guidelines. There were 110 patients who completed this study which produced highly significant information. Nevertheless, further independent studies on a larger scale may still be needed to confirm the positive findings from this report.