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HairMax Laser Therapy Hair Growth Clinical Results



We take a look at the clinical evidence behind the HairMax laser therapy hair growth devices for hair loss. It's important to note these results may not represent the typical results that you will experience. We recommend that you also take a loot at our blog: Will a HairMax Laser Device help with my hair loss? to ensure that the laser therapy hair growth devices are right for your type of hair loss.

 

Does the HairMax laser device really work for hair growth?

HairMax has invested in more clinical studies on light energy for hair growth than any other company to date. Seven clinical studies with 460 men and women have been completed on HairMax Laser devices. These clinical studies were conducted at top medical research centers such as the Cleveland Clinic, the University of Miami and University of Minnesota and have resulted in 7 FDA 510(k) Clearances. The studies were designed to support 510(k) submissions to the FDA and were approved by an IRB (Independent Review Board) and complied with GCP (Good Clinical Practices) guidelines and monitored by a CRO (Contract Research Organization).

Clinical studies

The clinical studies included males & females between the ages of 25-60 years with a diagnosis of Androgenetic Alopecia who had been experiencing active hair loss within the last 12 months. The inclusion criteria for males required a Norwood-Hamilton classification of IIa to V and Fitzpatrick skin types I to IV. An explanation of the Classification Charts is given in our blog: Will a HairMax Laser Device help with my hair loss? The inclusion criteria for females required a Ludwig (Savin) classification of I-4, II-1, II-2, or frontal.


All subjects were randomised for laser hair loss treatment analysis. A biostatistician calculated the study to be of a proper size to gauge statistically significant results of hair growth and hair density. Subjects were instructed to use the laser hair growth treatment device three times per week on non-consecutive days, 10-15 minutes per treatment for a total of 26 weeks. Hair density measurements were performed at baseline, at 16 and 26 weeks. Additional clinical visits were scheduled to monitor the laser hair loss treatment progress and overall hair growth.



Clinical studies show that HairMax Laser hair growth treatment users experienced:

  • Significant hair growth

  • Reversal of the thinning process

  • Increased density and fullness

  • Average hair count increase: 129 hairs / sq. in

  • A substantial decrease in hair fallout

  • Increased rate of hair growth

  • More manageability of the hair

  • Overall better quality and condition of hair






Published articles

In April 2014 The American Journal of Clinical Dermatology published a multicentre, randomised, sham device-controlled, double-blind study into the Efficacy and Safety of a Low-level Laser Device in the Treatment of Male and Female Pattern Hair Loss.


Key conclusions

  • Statistically significant increase in terminal hair density (thickness)

  • Higher percentage of LaserComb treated subjects reported overall improvement of hair loss condition and thickness and fullness of hair

  • Increase in hair counts was comparable to short-term clinical trials of the other FDA cleared drugs.

  • No serious side effects.


Key conclusions

  • 88% of patients showed significant improvement with the Lasercomb added to the drug treatment

  • 100% of all patients treated with the Lasercomb after discontinuation of drug treatment showed significant improvement

  • Improvement was observed as early as 3 months

  • Efficacy sustained up to maximum observation time of 24 months.

  • No adverse reactions reported

In May 2009 Clinical Drug Investigation published a clinical drug investigation looking at the effectiveness of HairMax laser phototherapy in male androgenetic alopecia.


Key conclusions

  • Subjects in the lasercomb treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in sham group

  • Significant improvements in overall hair regrowth were demonstrated in terms of patients’ subjective self-assessment.

  • No serious adverse events reported and no differences in adverse effects between lasercomb and sham device subjects


In 2003 the International Journal of Cosmetic Surgery and Aesthetic Dermatology published a study looking at Hair Regrowth and Increased Hair Tensile Strength Using the HairMax Lasercomb for Low-Level Laser Therapy.


Key conclusions

  • LaserComb stimulated hair growth

  • Increased tensile strength of hair in men and women

  • Effective in both vertex and temporal areas


Before and after pictures of users of HairMax laser hair growth devices


The photos shown below are of actual HairMax Laser device users, but are not intended to represent the results for everyone who uses the device will necessarily experience.


Filling in of hairline. Substantial increase in hair density. Overall improvement of hair quality.

Substantial increase in hair density. Overall improvement of hair quality

Clinical study non-velus 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 during the laser hair growth treatment. Subjects were evaluated at baseline, week 8, week 16 and week 26.


 
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