1. Clin. Drug Invetig. 2009, 29 (5) :283-92. doi: 10.2165/00044011-200929050-00001.

HairMax Laser Comb laser phototherapy in the treatment of male androgenetic alopecia: a randomized, double-blind, 'counterfeiting' device multi-centered research.

Leavitt M, Charles G, Heyman E, Michaels D.
Private Dermatology Practice, Maitland, Florida, USA.

Background and objective:
The use of low levels of near infrared light for the reduction of pain, inflammation and edema, promoting the healing of wounds, deep tissue and nerves, and the prevention of damage to the tissue 40 has been recognized since the invention of the laser. The HairMax Laser Comb is a portable class 3R lower-level laser therapy device comprising a single laser module of 7.9 or 12 emulsified rays having a wavelength of 655 nm (+ / - 5%). The device contains a technique that separates hair from the users through the combs. This improves the delivery of the laser light on the scalp. The combs are designed so that each of the teeth coincides with the laser beam. By aligning the teeth with the laser beams the hair can be separated and the laser energy can be delivered to the scalp of the user without hindrance from the individual hairs on the scalp.

The primary objective of the study was to assess the safety and efficacy of the HairMax Laser Comb in the promotion of hair growth and in stopping hair loss in men diagnosed with alopecia Androgenetica (AGA).

This double-blind 26-week-long trial with randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax Laser Comb or 'fake' device (2: 1). The 'fake' device used in the study was identical to the active device, except that the laser light has been replaced by a non-active light bulb.

Of the 110 patients who completed the study, subjects in the HairMax Laser Comb treatment group showed a significantly greater increase in average terminal hair density than subjects in the 'fake' group (p <0.0001). In accordance with this evidence of primary effectiveness, significant improvements in overall hair growth demonstrated in terms of subjective assessments of patients (p <0.015) after 26 weeks compared to the hairline. The HairMax Laser Comb was well tolerated with no serious adverse events reported and no statistical difference in adverse events between the study groups.

The results of this study suggest that the HairMax Laser Comb is an effective, well tolerated and safe laser phototherapy device for the treatment of alopecia Androgenetica in men.

PMID: 19366270 (PubMed - indexed for MEDLINE) seek to establish additional international medical device registrations and further the credibility of the HairMax Laser Comb on the world market worldwide.

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