Summary clinical studies

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).

Methods:
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 The 'fake' device used in the study was identical to the active device, except that the laser light has been replaced by a non-active light bulb.

Results:
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.

Conclusion:
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.

Back to clinical studies.

We welcome you to our website and we invite you to read on and find out why HairMax is the world's leading laser hair loss treatment and a true breakthrough in Hair Growth, Hair Care and Hair Science. Androgenic alopecia also known as male and female pattern hair loss, are generally considered to be caused by changes in the levels of hormones, notably androgens, that affect hair growth. Heredity can also be a major factor in the development of these conditions. Male pattern hair loss affects an estimated 50 million men and female pattern hair loss affects 30 million women in the United States alone. The HairMax LaserComb is a low level laser medical device designed to treat this condition via the science of Photo BioStimulation. The HairMax LaserComb is a proven hair loss solution and is the only laser phototherapy device Cleared for marketing by the FDA for the treatment of androgenetic alopecia and the promotion of hair growth in both men and women.

With regular use, users can expect to see the growth of thicker, fuller hair in as little as 12 weeks. Best of all, users can achieve fuller, thicker hair, without a prescription and in the comfort of their own home. The HairMax is a stand alone hair loss treatment with no recurring costs and its precision lasers have a lifespan of 10 to 15 years. The lasers in the HairMax LaserComb are what promotes the hair growth, and no other creams, gels or surgery are necessary for exceptional results.

Our website contains a wealth of information on how the HairMax works to treat hair loss including, a background on the science behind the HairMax, a comprehensive review of our clinical studies treating Hair Loss with the HairMax and an archive of hair loss success stories both in the media and from HairMax users worldwide. Once you've researched what promotes hair growth, and how laser technology is the leading, proven laser hair regrowth treatment for baldness, hair loss and thinning hair, you too will join the hundreds of thousands of men regrowing hair and enjoying thicker, healthier hair with the HairMax LaserComb.

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