Key Clinical Studies on the HairMax LaserComb

Since 2001, there have been 7 clinical studies conducted on the HairMax. In 2010, 2 of the studies were conducted on males and 2 were conducted in females.

Clinical Results

• Significantly greater increase in mean terminal hair count than subjects in the control group.
• Significantly better subjective assessments of thickness and fullness of hair than subjects in the control group.
• No subject experienced a serious adverse event from the laser hair loss treatment.
• Adverse event profiles were similar between the HairMax and control groups.
  
  

Users of the HairMax LaserComb® laser hair growth treatment* received some or all of the following subjective benefits:

• A substantial decrease in hair fallout.
• Some users experienced an initial increase in telogen fallout after starting treatment, but after this period, new anagen growth was observed.
• Increased speed of hair growth.
• More manageability of the hair.
• Overall better quality and condition of hair.
  
  
  

The photos shown above are of actual HairMax LaserComb users, but are not intended to represent results everyone who uses the device will necessarily experience. Qualified subjects had global images recorded at each visit using a stereotactic device. 

Non-Vellus Hair Density Macro Images

 
Actual clinical study photo above shows 29 hair/cm increase after 26 weeks of laser hair growth treatment.

Study Objectives

Study Design

All studies were designed as a multi-centered, double- blinded, randomized control-device trials conducted at eight sites in the United States. 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 immediately prior to randomization and again at 16 and 26 weeks. Additional clinical visits were scheduled to monitor the laser hair loss treatment progress and overall hair growth.

Subject Population and Demographics

The study population included males and females between the ages of 25 and 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. The inclusion criteria for females required a Ludwig (Savin) classification of I-4, II-1, II-2, or frontal. All subjects were randomized 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.

Lexington limited the skin types for the subjects in the studies to Fitzpatrick I to IV to facilitate the hair counting process. It is difficult to count dark hairs on dark skin and therefore the darker Fitzpatrick skin types (V and VI) were not included in the study.

Methods

After diagnosing the scalp for Androgenetic Alopecia and exclusion of other dermatological conditions, subjects were randomized with either our active laser hair loss treatment device, or sham device. Subjects were then photographed for global evaluation and the target site of the scalp was identified and tattooed for baseline density. Subjects were then provided a device without usage instructions from the investigator per the protocol for OTC use. Subjects returned to the clinic at 8 and 16 weeks with a final visit at week 26 for clinical evaluation of hair counts and hair growth.

Prior Studies

Калі ласканацісніце тут to read about our prior clinical studies with the HairMax LaserComb®.

* Пашыраны HairMax 7, Lux 9 і Professional 12 мадэляў пазначаны для лячэння андрагеннай алапецыі, а таксама спрыяць росту валасоў умужчыныхто Норвуд Гамільтан класіфікацыі IIa да V, а ўжанчын, Якія Людвіг (Савін) I-4, II-1, II-2, ці франтальнай мадэлі выпадзення валасоў, а хто абодва Тыпы скуры Фіцпатрык я да IV.