The results of the first clinical study were published in April 2014, in the peer-review journal, American Journal of Clinical Dermatology with over 134 citations to date: Am J Clin Dermatol (2014) 15:115–127
To determine whether treatment with a low-level laser device, the US FDA-cleared Hairmax Lasercomb®, increases terminal hair density in both men and women with pattern hair loss.
“Before and after global photographs and macrophotographs below demonstrated increases in terminal hair density, most likely through the conversion of vellus or intermediate follicles to terminal follicles or from resting telogen follicles to active anagen follicles. Male and female pattern hair loss before and after lasercomb treatment. Global photographs of a female subject, at baseline (a) and after 26 weeks (b) of the 12-beam lasercomb treatment. Macrophotographs of a male subject, at baseline (c) and after 26 weeks (d) of the 9-beam lasercomb treatment.
Increased hair count through conversion of vellus or intermediate follicles to active follicles producing terminal hair (ovals) or resting telogen to active anagen follicles (rectangles) is highlighted”. (See article for compete details)
To read this article in its entirety, click here.
Meta Analysis of the Four Clinical Studies of Males and Females in the Article Above
Individual study results were all statistically significant and least squares mean differences ranged from 12.9 to 17.3 at week 16 and from 11.3 to 17.2 at week 26. Homogeneity assessment results were non-significant for both week 16 (p=0.8070) and week 26 (p=0.6188), thus supporting the constancy of a treatment effect across the studies at both time points. Meta analysis overall results were highly statistically significant (p<0.0001) at both week 16 and week 26 with least squares mean differences at 14.01 and 15.27 at week 16 and week 26, respectively.
Conclusions and relevance
We observed a statistically significant difference in the increase in terminal hair density between lasercomb- and sham-treated subjects. No serious adverse events were reported.
The study also compared the short term clinical results found with minoxidil and finasteride to those found with the Hairmax LaserComb were comparable.
Our results suggest that low-level laser treatment may be an effective option to treat pattern hair loss in both men and women. Additional studies should be considered to determine the long-term effects of low-level laser treatment on hair growth and maintenance.
The results of this clinical study were also published in April 2014 – June 2014, in the peer-review journal, International Journal of Trichology.
Munck A, Gavazzoni MF, Trüeb RM
OBJECTIVE
To evaluate the efficacy of the 655 nm-Hairmax Laser Comb ® either as monotherapy or as concomitant therapy for treatment of male and female AGA, we performed a retrospective observational study of global photographic assessments of patients in an office-based setting.
MATERIALS AND METHODS
RESULTS
Hairmax Laser Comb® was used as monotherapy in six patients (two female, four male), and as a concomitant therapy in 26 patients (19 female, seven male).
In summary, eight patients (three female, five male) showed significant improvement, 20 patients (14 female, six male) moderate improvement, and four patients (four female, zero male) no improvement
There was no statistically significant difference between LLLT monotherapy and concomitant therapy with either minoxidil and/or finasteride and regarding male or female AGA (Table 4)
Figure 2: Monotherapy in a 54-year-old male (a) Before treatment, and improvement after (b) 6 months, and (c) 12 months of low-level laser therapy
Figure 3: Concomitant treatment with topical 5% minoxidil in a 55-year-old male adding on low-level laser therapy (LLLT) to 4 year pretreatment with 5% topical minoxidil solution (a) Before, and (b) After 3 months of added LLLT
Figure 4: Concomitant treatment with topical 5% minoxidil and 1 mg oral finasteride in a 34-year-old male (a) Before, (b) After 9 months treatment with 1 mg oral finasteride and topical 5% minoxidil solution bid, and (c) After 3 months after adding on low-level laser therapy
The results of this study were published in the May 2009 issue of the peer review journal, Clinical Drug Investigation.
Leavitt M, Charles G, Heyman E, Michaels D
Studies Objectives
The studies were designed to support the 2007 510K submission to the FDA and was subjected to an IRB approval and complied in accordance with GCP (Good Clinical Practices). The objectives of the study in males were to assess the following:
Study Design
This studies was designed as a multi-center, randomized, sham-device controlled trial conducted at multiple sites in the United States. Subjects were to use the device three times per week on non-consecutive days for a total of 26 weeks. Hair count measurements were performed at baseline immediately prior to randomization and again at 8, 16 and 26 weeks.
Global Images
Qualified subjects had global images recorded at each visit using a stereotactic device. The global images above correspond with the unretouched Macro images below.
Subject Population and Demographics
The study population was males between the ages of 25 and 60 years with a diagnosis of androgenetic alopecia who had been experiencing active hair loss with the last 12 months. The inclusion criteria required a Norwood-Hamilton classification or IIa to V, and Fitzpatrick Skin Type I to IV. All subjects were randomized. A biostatistician calculated the study to be of a proper size to gauge statistically significant results.
Methods
After an assessment of the scalp for androgenetic alopecia and exclusion of other dermatological conditions, subjects were randomized with either active or sham devices. Subjects were then photographed for global evaluation, had the target site of the scalp identified and tattooed for baseline density and were given the device without investigation usage instructions per protocol for OTC use. Subjects returned to the clinic at 8 and 16 weeks with a final visit at week 26 for clinical evaluation.
RESULTS
110 Subjects completed study:
GLOBAL IMAGES – Before and After
Non-Vellus Hair Density Macro Images
At baseline, a circle approximately 1 inch in diameter, positioned in the transition zone of the scalp, was identified as the site for hair clipping and tattooing. Within this site was the target area for the hair density evaluation. Subjects were evaluated at baseline, week 8, week 16 and week 26 Digital images captured by FUJI S2 were taken of the target site within the clipped area following the site preparation. A 21 inch monitor was used for blinded evaluation.
