Clinical studies with the HairMax Laser Comb



  • 7 clinical studies were conducted with 460 subjects
  • The results of the study are used to support the FDA 510 (k) Submission
  • HairMax treated hair loss and promoted hair growth in 93% of the users
  • There are never reported negative side effects of the treatment
  • The advantages of the use of the HairMax Laser Comb are a decrease in hair loss, more manageability of the hair, and an overall better quality and condition of the hair

 

7 multi-centered, double-blind, randomized studies with 460 subjects were performed using the HairMax Laser Comb at the best medical research centers such as Cleveland Clinic, the University of Miami and the University of Minnesota.

The clinical studies included men and women aged between 25 and 60 years with a diagnosis of Androgenetic Alopecia who have had active experience hair loss in the last 12 months.

The subjects were instructed to use the laser hair treatment on non-consecutive days, 10-15 minutes per treatment, three times a week for a total of 26 weeks. Hair density measurements were carried out on the baseline after 16 and 26 weeks. The additional clinical visits were scheduled to progress and overall hair growth laser to monitor treatment.

Study objectives:
 
  • Promote hair growth through changes in hair count.
  • Termination of hair loss.
  • General improvement in the health of the scalp.
  • Safety.

Study inclusion criteria

The clinical studies included men and women aged between 25 and 60 years with a diagnosis of Androgenetic Alopecia who have experienced hair loss in the last 12 months. The inclusion criteria for men required a Norwood-Hamilton classification of II to V and Fitzpatrick classification I to IV. The inclusion criteria for women required a Ludwig classification of I-4, II-1, II-2 or frontal. All subjects were randomized for the laser analysis hair loss treatment. A biostatic calculated the study which must be of a proper size to measure statistically significant results of the hair growth and hair density.


 

Lexington limited skin types for the subjects in the studies to Fitzpatrick I to IV to facilitate counting the hairs. It is difficult to count dark hairs on a dark skin so dark Fitpatrick skin types (V and VI) are not included in the study.
 

Methods

After the diagnosis of androgenetic alopecia and exclusion of other dermatological conditions, subjects were randomized to either use our active laser hair loss treatment device or a counterfeit device. The subjects were then photographed for global evaluation and were 'tattooed' for the baseline density. After that the subjects got the device without a manual per protocol of the researchers for OTC use. The subjects returned to the clinic after 8, 16 and 26 weeks for clinical evaluation of the hair count and hair growth.
 
Hair density macro photos

At the start, a circle of 1 cm in diameter, placed in the transition zone of the scalp, was identified as the location for cutting hair. the target was within this location for the hair density evaluation during laser hair growth treatment. The subjects were evaluated at baseline, at week 8, week 16 and week 26. Digital images of the marked location were taken By a Fuji S2 in the clipped area due to the preparation of the site.  A 19-inch monitor was used for blind evaluation.

The images below correspond to the non-retouched macro images, and to show that there is a 20% increase in hair growth density.

 



The actual study picture above shows an increase of 29 hairs / cm after 26 weeks of treatment with the HairMax Laser Comb.

 

Results of the clinical studies

Patients in the HairMax Laser Comb treatment group had:
  • Significantly greater increase in the average terminal hair count than subjects in the 'fake' group.
  • Significantly better subjective assessments of the thickness and fullness of the hair then subjects in the 'fake' group.
  • None of the subjects experienced serious side effects of laser hair loss treatment.
  • None of the subjects experienced serious side effects of laser hair loss treatment.

(control device = group with 'fake' product)


Users of the HairMax Laser Comb laser hair growth treatment received some or all of the benefits below:

 
  • A substantial decrease in hair loss.
  • Some users experienced an initial increase in the telogen hair loss after the start of the treatment, but after this period, new anagen growth was observed.
  • Increased speed rate of hair growth.
  • More manageability of the hair.
  • Better quality and condition of the entire head of hair.

Qualified subjects had taken global pictures using a stereotactic device in each visit.


Significant increase in hair density. Overall improvement of its quality.
 


Completing the hairline. Significant increase in hair density.
General improvement of the hair quality.

 

The photos are taken by real HairMax Laser Comb users above, but are not intended to represent the results for each user of this device.
Qualified subjects had taken global pictures that are recorded at each visit using a stereotactic device.

The results of the most important clinical study performed with the HairMax Laser Comb led to FDA approval for the product in the market place, which was published in May 2009 Clinical Drug Investigation. The article entitled, HairMax LaserComb Phototherapy Device in the treatment of Male Adrogenetic Alopecia, is indexed as Clin Drug Invest 2009: 29 (5): 283-292 'in most of the biomedical databases such as Medline, Embase / Exerpta Medica, etc .


Click here to read the Summary of the study.