对HairMax激光生发梳关键临床研究
 
Learn the facts about the HairMax LaserComb
  • 自2001年以来，7临床研究已经进行的460课题
  • Key clinical study on the HairMax published in peer review journal
  • Results of study used to support HairMax LaserComb FDA 510(k) submission
  • HairMax雷射治疗脱发和促进头发生长在93％的用户
  • No serious side effects ever reported from treatment with the HairMax
  • Benefits of using the HairMax: decrease in hair fallout, increased speed of hair growth, more manageability of hair and overall better quality and condition of hair
 

自2001年以来，先后有7对HairMax雷射进行临床研究。 2010年，该研究进行了2对男性和女性进行了2人。



Clinical Results


Subjects in the HairMax LaserComb® laser hair treatment group had:

  • 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.

Mean Terminal Hair Count Changes in Males from HairMax Clinical Study Mean Terminal Hair Count Changes in Females from HairMax Clinical Study

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.

HairMax LaserComb clinical study before and after photo - Female

HairMax LaserComb clinical study before and after photo -Male


上面的照片是实际HairMax激光生发梳的用户，但并不代表结果大家谁使用的设备将一定的经验。合格的受试者全球图像记录每个用立体定向设备的访问。

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 during the laser hair growth treatment. 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 19 inch monitor was used for blinded evaluation. 

下面的图片对应于未修饰宏图像显示和表现出的头发生长密度增加20％。

 Un-retouched macro image shows 20% increase in hair count with HairMax LaserComb
Actual clinical study photo above shows 29 hair/cm increase after 26 weeks of laser hair growth treatment.





Study Objectives
 
促进头发生长的头发数量的变化，通过
 cessation of hair loss
 overall scalp health
 safety
 

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

研究人群包括25岁之间的和60的雄性秃的诊断谁已经历了过去12个月内积极脱发岁男性和女性。男性入选标准要求的第IIa诺伍德 - 汉密尔顿分类V和菲茨帕特里克皮肤类型I至IV。而女性的入选标准要求的I - 4路德维希（萨万）的分类，II - 1，II - 2，或额部。所有受试者进行激光治疗脱发的随机分析。一个生物统计学家计算的研究，以一个合适的大小是衡量头发生长和头发密度显着的效果。


在有限的列克星敦研究科目的皮肤类型菲茨帕特里克第一至第四，方便发点票过程。我们很难指望黑皮肤黑头发，所以颜色较深的皮肤类型菲茨帕特里克（V和VI）未纳入研究。


Methods


经诊断为雄性秃和其他皮肤病的条件排除头皮，受试者要么我们积极与激光治疗脱发设备，设备随机或假。受试者然后拍下全球评估和头皮的目标站点被确定为基准密度纹身。受试者则没有提供从每对场外协议研究者使用说明使用的设备。主题返回8和16周的临床与26周的头发计数和头发生长的临床评价的最后访问。
 

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 an abstract of this study 


Prior Studies


Please click here to read about our prior clinical studies with the HairMax LaserComb®.
 
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。