“1: Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.Links
HairMax LaserComb(R) Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia: A Randomized, Double-Blind, Sham Device-Controlled, Multicentre Trial.Leavitt M, Charles G, Heyman E, Michaels D.
Private Dermatology Practice, Maitland, Florida, USA.

The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting 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(R) is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user’s hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb(R) laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA). This double-blind, sham device-controlled, multicentre, 26-week trial randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax LaserComb(R) or the sham device (2 : 1). The sham 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(R) treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the sham device group (p < 0.0001). Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients’ subjective assessment (p < 0.015) at 26 weeks over baseline. The HairMax LaserComb(R) 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(R) is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.

PMID: 19366270 [PubMed - in process]

Study proves clinical efficacy of the HairMax LaserComb in the treatment of Androgenetic Alopecia in males commonly known as ‘male pattern baldness’
April 27 , 2009 – Boca Raton, FL – Findings of the pivotal clinical trial of the HairMax Laser Comb that provided clear evidence of efficacy and safety to the U.S. Food and Drug Administration will be published in the prestigious peer review journal, Clinical Drug Investigation) in May 2009. Results of the clinical trial were a key factor in the clearance of the device for marketing in January 2007 for the promotion of hair growth in males with Androgenetic Alopecia.

The six-month study, titled, “Double-blind Efficacy Trial of HairMax LaserComb® Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia,” demonstrates that the device should be considered as first line therapy for all appropriate men with this condition.

According to Mr. Leonard Stillman, Director of Professional Services at Lexington International, “This is the first controlled clinical trial published that proved the clinical efficacy and safety of a laser phototherapy device for treating hereditary hair loss.”

Clinical assessment of treated scalp sites was carried out by objective evaluation of macro-images using dot mapping and computer aided hair counts, and with subjective evaluations by physicians and patients. The study showed that the HairMax LaserComb is an effective and well tolerated laser phototherapy device for the treatment of certain classes of Androgenetic Alopecia in males. The adverse event profile was similar in the two treatment groups and there were no reports of serious adverse events.

According to Mr. Stillman, “The HairMax LaserComb was introduced to the medical community in 2007. Since then, a large number of dermatologists have adopted the device for their patients and it has become a mainstay in their treatment protocols for this psychologically distressing condition.”

Mr. Stillman also noted that male pattern baldness affects more than 50 million men in the U.S and many more millions of men worldwide.
Study Design and Results
The four-center, double-blind, sham-device (placebo), controlled study was designed to compare the results of treatment of subjects randomized in a blinded fashion to either the HairMax LaserComb or the sham device per a protocol approved by an Investigational Review Board (IRB) and performed in accordance with Good Clinical Practices. Subjects were required to have a Norwood Hamilton classification of IIa to V based on the Male Classification System of Hair Loss, and have Fitzpatrick Skin Type Scale I through IV.
Of the patients who completed the six-month study, subjects in the HairMax LaserComb treatment group exhibited significantly greater increase in mean terminal hair density than that seen in subjects treated with the sham-device.
Mr. Stillman further commented, “The results of the study accomplished an important goal. By conducting a well designed and controlled efficacy trial, results showed that the HairMax LaserComb is truly an effective, convenient, well-tolerated treatment for hair loss caused by Androgenic Alopecia in males”.