Complete Information on 3 Published Clinical Studies

Third Study

The results of the first clinical study were published in April 2014, in the peer-review journal, American Journal of Clinical Dermatology:

Efficacy and Safety of a Low-Level Laser Device in the Treatment of Male and Female Pattern Hair Loss: A Multicenter, Randomized,
Sham device-controlled, Double-Blind Study

 

Joaquin J. Jimenez, Tongyu C. Wikramanayake, Wilma Bergfeld, Maria Hordinsky, Janet G. Hickman, Michael R. Hamblin, Lawrence A. Schachner

Objective:

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.

Methods

 

  • Randomized, sham device-controlled, double-blind clinical trials
  • conducted at multiple institutional
  • A total of 146 male and 188 female subjects with pattern hair loss were screened.
  • A total of 128 male and 141 female subjects were randomized to receive either a lasercomb (one of three models) or a sham
  • Treatment on the entire scalp three times a week for 26 weeks.
  • Terminal hair density evaluated at baseline and at 16- and 26-week follow-ups
Results – Mean terminal hair count at 26 weeks

 

  • 20.2 cm2 – 9-beam lasercomb-treated female subjects,
  • 20.6 cm2 – 12-beam lasercomb-treated female subjects,
  • 18.4 cm2 – 7-beam lasercomb-treated male subjects, and
  • 25.7 cm2 – 9, 12 lasercomb-treated male subjects respectively
  • Increase in terminal hair density was independent of the age and sex of the subject and the lasercomb model.
  • A higher percentage of lasercomb-treated subjects reported overall improvement of hair loss condition and thickness and fullness of hair in self-assessment, compared with sham-treated subjects.
  • No serious adverse events were reported in any subject receiving the lasercomb in any of the four trials.

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.

Second Study

The results of this clinical study were also published in April 2014 – June 2014, in the peer-review journal, International Journal of Trichology.

Use of Low-Level Laser Therapy as Monotherapy for Male and Female Androgenetic Alopecia

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

  • The study design was retrospective and observational.
  • Patients who had purchased a HairMax Laser Comb ® between July 2011 and July 2013 for treatment of AGA
  • Patients on concomitant treatment had been treating with topical minoxidil or oral finasteride for at least 9 months, before starting therapy with the HairMax Laser Comb ® .
  • Patients used the HairMax Laser Comb ® at home 3 times weekly between 8 and 15 min depending on the model purchased
  • Global photographs were performed at 3, 6, 12, and 24 months of
  • Global photographs were evaluated by two of the authors
  • Scored as significant, moderate, or no improvement. In the case of diverging opinions, the inferior score was given.

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

Monotherapy group (Figure 2):

  • Two patients (one female, one male) showed significant improvement
  • Four patients (one female, three male) moderate improvement
  • Zero patients no improvement

In the concomitant therapy group (Figure 3)

  • Six patients (two female, four male) showed significant improvement (four female, zero male)
  • Four patients (one female, three male) moderate improvement
  • Zero patients 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

First Study – Pivotal Study Leading to FDA Clearance

The results of this study were published in the May 2009 issue of the peer review journal, Clinical Drug Investigation.

HairMax LaserComb® Phototherapy Device in the Treatment of Male Androgenetic Alopecia.

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:

  • promotion of hair growth through changes in hair count
  • cessation of hair loss
  • scalp overall health
  • safety

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:

  • All subjects exhibited a significantly greater increase in mean terminal hair density than subjects in sham device group (p<0.0001)
  • Patients subjective assessment showed significant improvement in hair regrowth
  • No serious adverse events were reported

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.