Background and objective: 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® 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® laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA).
Methods: 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® 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.
Results: Of the 110 patients who completed the study, subjects in the HairMax LaserComb® 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® was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups.
Conclusions: The results of this study suggest that the HairMax LaserComb® is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.
Hair Follicle Hair Loss Hair Growth Minoxidil Hair Density
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
This is a preview of subscription content, log in to check access.
This study was sponsored by Lexington International, LLC. Mr D. Michaels is an employee of Lexington International, LLC. Dr M. Leavitt is a retained consultant and medical advisor and Dr G. Charles is a non-retained medical advisor to Lexington International, LLC. Dr Eugene Heyman has no conflicts of interest that are directly relevant to the content of this study. The authors would like to gratefully acknowledge Dr Maksim Plikus for assistance with the compilation of this article.
Hawkins D, Houreld N, Abrahamse H. Low level laser therapy (LLLT) as an effective therapeutic modality for delayed wound healing. Ann N Y Acad Sci 2005; 1056: 486–93PubMedCrossRefGoogle Scholar
Mester E, Szende B, Gartnerne TJ. Influence of laser beams on the growth of hair in mice. Kiserl Orvostud 1967; 19: 628–31Google Scholar
Bibikova A, Oron U. Promotion of muscle regeneration in the toad (Bufo viridis) gastrocnemius muscle by low-energy laser irradiation. Anat Rec 1993; 235: 374–80PubMedCrossRefGoogle Scholar
Reddy GK. Comparison of the photostimulatory effects of visible He-Ne and infrared Ga-As lasers on healing of impaired diabetic rat wounds. Lasers Surg Med 2003; 33: 344–51PubMedCrossRefGoogle Scholar
Byrnes KR, Barna L, Chenault VM, et al. Photobiomodulation improves cutaneous wound healing in an animal model of type II diabetes. Photomed Laser Surg 2004; 22: 281–90PubMedCrossRefGoogle Scholar
de Carvalho PT, Mazzer N, dos Reis FA, et al. Analysis of the influence of low-power He-Ne laser on the healing of skin wounds in diabetic and non-diabetic rats. Acta Cir Bras 2006; 21: 177–83PubMedGoogle Scholar
Loevschall H, Arenholt-Bindslev D. Effect of low level diode laser irradiation of human oral mucosa fibroblasts in vitro. Lasers Surg Med 1994; 14: 347–54PubMedCrossRefGoogle Scholar
Vink EM, Cagnic BJ, Cornelissen MJ, et al. Increased fibroblast proliferation induced by light emitting diode and low-power laser irradiation. Lasers Med Sci 2003; 18: 95–9CrossRefGoogle Scholar
Pal G, Dutta A, Mitra K, et al. Effect of low intensity laser interaction with human skin fibroblast cells using fiber-optic nano-probes. J Photochem Photobiol 2007; 86: 252–61CrossRefGoogle Scholar
Mirzaei M, Bayat M, Mosafa N, et al. Effect of low-level laser therapy on skin fibroblasts of streptozotocin-diabetic rats. Photomed Laser Surg 2007; 25: 519–25PubMedCrossRefGoogle Scholar
Pereira AN, Eduardo Cde P, Matson E, et al. Effect of low-power laser irradiation on cell growth and procollagen synthesis of cultured fibroblasts. Lasers Surg Med 2002; 31: 263–7PubMedCrossRefGoogle Scholar
Schindl A, Schindl M, Schön H, et al. Low-intensity laser irradiation improves skin circulation in patients with diabetic microangiopathy. Diabetes Care 1998; 21: 580–4PubMedCrossRefGoogle Scholar
Saygun I, Karacay S, Serdar M, et al. Effects of laser irradiation on the release of basic fibroblast growth factor (bFGF), insulin like growth factor-1 (IGF-1), and receptor of IGF1(IGFBP3) from gingival fibroblasts. Lasers Med Sci 2007; 23: 211–5PubMedCrossRefGoogle Scholar
Tiede S, Kloepper JE, Bodò E, et al. Hair follicle stem cells: walking the maze. Eur J Cell Biol 2007; 86: 355–76PubMedCrossRefGoogle Scholar
Plikus MV, Sundberg JP, Chuong CM. Mouse skin ectodermal organs. In: James Fox, Stephen Barthold, Muriel Davisson, et al., editors. The mouse in biomedical research. New York (NY): Academic Press, 2006: 691–694Google Scholar