HairMax LaserComb Research
 
  • HairMax success measured in number of people whose lives are enriched
  • Field experience with the HairMax supports clinical study that device is highly efficacious
  • Field research demonstrates 93% user satisfaction with the HairMax
  • 2010 - 关键HairMax雷射的临床研究表明，女性的疗效
  • 2010 - 临床研究表明，男性与3个新车型的疗效
  • 2005年的主要临床和科研的HairMax雷射的研究表明，男性疗效
  • 2003 - first HairMax IRB study showed 84.2% success in hair growth and over 45% hair count increase
  • 2002 - HairMax雷射独立研究表明78.9％的增幅在93.5％的拉伸强度和头发计数增加。
 
 

Lexington International, LLC is a leader in hair growth, hair care and hair science. Our primary objective is to help those suffering from androgenetic alopecia. Our goal is to provide an effective treatment that is affordable, easy to use and provides noticeable results without adverse side effects. Lexington bases its success on the number of people whose lives are enriched. We truly care about conducting our business ethically and appropriately. 


Female using HairMax LaserComb Lux9Our clinical Studies correlate directly with our field experience demonstrating that the HairMax LaserComb is a highly efficacious treatment for certain cases of androgenetic alopecia. The science behind Laser PhotoTherapy and PhotoBioStimulation is very practical. Usage of the HairMax LaserComb to date has been substantial. We have satisfied users in over 150 countries and have gained strong support from leading hair luminaries. Our extensive feedback overwhelmingly shows a positive user experience. Along with strong clinical data we believe that a key success criteria is user experiences - this is an area where we believe the HairMax LaserComb excels. Our field research demonstrates that 93% of HairMax users are satisfied with the results of their HairMax LaserComb.

 
Along with forging ahead with an active clinical agenda, we are committed to aiding clinical hair research and adding to scientific literature.
 
Below are descriptions of studies conducted by Lexington which have helped to further knowledge on the treatment of hair loss. These studies have helped to validate the efficacy of the HairMax LaserComb in hair growth and have made the device an important part of the overall treatment for hair loss.
 

2010 - 关键在510（K）提交的支持给FDA的临床研究，并随后在2011年清理市场
 

一个双盲，对照临床研究设备完成的主要研究中心的资格和量化作为在治疗女性雄激素性秃发（脱发）使用医疗器械的HairMax雷射的疗效。介于25至60岁的患者，被列入六个月的试用期。发计数测量基线，16周和26周的最后一次访问。此外，在HairMax雷射组受试者报道显着提高头发的厚度和密度增加。

在六个月期间结束时，在研究对象的100％显示，平均超过20％，所有患者的头发数量增加成功的新的头发生长。这些数字医学和科学意义。

2009 - Evaluation of the Activity of Laser Doses on Ex-Vivo Hair Growth
 

一个比较不同的激光波长延伸的头发在一个特殊的培养基相比，不暴露于激光能量的研究结果进行。经过10天每天接触到的各种波长的结果表明，它们都与控制毛发没有表现出伸长长的头发。
 

2005 - Key Clinical Study in Support of 510(k) Submission to the FDA and Subsequent Clearance to Market in 2007
 
The results of the key clinical study performed with the HairMax LaserComb which led to FDA clearance to market was published in the May 2009 Issue of Clinical Drug Investigation. The article entitled, HairMax LaserComb Phototherapy Device in the Treatment of Male Androgenetic Alopecia, is indexed as Clin Drug Invest 2009: 29 (5): 283-292 in most of the biomedical databases such as MEDLINE, EMBASE/Excerpta Medica, etc.

Please click here to read about this study
 
 

2003 - First IRB Clinical Study 
 

Clinical studies were performed under an Independent Review Board protocol at a leading research center to qualify and quantify the efficacies of the HairMax as a medical device for use in treating androgenetic alopecia (hair loss). Patients, with ages ranging from 26 to 76, were included in a six month evaluation period. Study subjects were required to have thinning hair in the scalp area and have active hair loss at the time of entrance into the study. Analysis was conducted at two locations on the scalp, in the temporal and vertex areas.

Before use of the LaserComb began, each area was clipped and a high-resolution photograph of the location was made. These photographs were loaded into an imaging system that identified each hair shaft. After magnification, a standard hair count was carried out and the number was recorded for comparison later in the study. Following the initial marking and hair count, each patient was provided with a HairMax LaserComb®. They were instructed to use it twice a week for the prescribed time of approximately 10 minutes, covering the entire scalp twice with each treatment. 

FDA Cleared Laser comb, Laser Hair Therapy, FDA Cleared for Promotion of Hair Growth, Hair Loss Treatment
Image from our 2003 Clinical Study showing the methodologies used


Each month, the patient would return to the clinic to have the study areas clipped, new photographs taken and new hair counts recorded.

At the end of the six-month period, 97.4% of the patients in the study showed benefits from using the HairMax LaserComb®. Additionally, 84.2% of study participants showed successful new hair growth with an average hair count increase for all patients of over 45%. These numbers are significantly better than any other product tested to date for hair re-growth.
 

Response criteria
 
Benefit: Benefit to treatment was defined as lack of hair loss, or > 0% change from baseline in hair count.

Hair Growth: Success in hair growth was defined as an increase in hair count of > 11% from baseline.
 

Statistical Significance
 

All p-values for the study were statistically significant. The p-value (or the probability that a variate would assume a value greater than or equal to the observed value) for this study’s endpoint (<0.0001) indicates that the results of this study would have a very high probability of being valid across the general population. In other words, the general population of men and women suffering from hair loss would, in all probability, see the same hair count increases as seen by the patients in this study.


FDA Cleared Laser comb, Laser Hair Therapy, FDA Cleared for Promotion of Hair Growth, Hair Loss Treatment
Charts showing the increases in hair growth in the
frontal & vertex sites for Males

 

2002 - Study
 

The second clinical evaluation in 2002 was independently conducted, without any funding by Lexington, published by Dr. Michael Markou in the peer reviewed medical journal ‘International Journal of Cosmetic Surgery and Aesthetic Dermatology’. This evaluation on 35 individuals demonstrated an average of 78.9% increase in hair tensile strength and 93.5% increase in average hair counts.

Click here for the Study Report (PDF)
 

Initial Studies in Australia
 
Initial Research and development of the HairMax LaserComb® began in the 1980s in Sydney Australia where CEO Henry Pearl was a pioneer in the use of laser phototherapy in a clinical setting to activate hair growth. The results were dramatic with men experiencing substantial improvements in hair growth, regrowth and overall quality of hair.

The first clinical evaluation conducted in 1993 used a laser-based combination of laser irradiation, laser acupuncture and high frequency electrotherapy, with the proprietary name 'cell wave therapy'. The evaluation was performed over a 15-month period to ascertain its efficacy in delaying or reversing male androgenetic alopecia. The trial was divided into 3 phases, each of 5 months duration.

1st PHASE:  80% of the actively treated group showed a 27% mean increase in hair density at the end of the first phase…whilst the control group had a loss of 4.5%. This is a statistically significant trend to increase hair density, with a p value of 0.02.

2nd PHASE:  This increase in hair density was maintained by the actively treated group.

3rd PHASE:  After the actively treated group ceased therapy they had a significant loss of hair density with a p value of 0.001.
 
Customer Satisfaction is of Primary Importance
       Clinically Proven to Promote Hair Growth*
       Greater than 90% User Satisfaction Reported
       Patented and Manufactured in the USA
       ISO Quality Assured
       Proud Members of the Better Business Bureau
 

*间，HairMax高级7，力士9，和专业的12款车型都表示治疗雄激素性脱发，促进头发生长男性第IIa诺伍德汉密尔顿分类V和女性路德维希（Savin）的I - 4，II - 1，II - 2，或脱发的正面图案，谁都有菲茨帕特里克皮肤类型I至IV。