HairMax LaserComb에 주요 임상 연구
 
Learn the facts about the HairMax LaserComb
  • 2001 년 이후, 7 임상 연구는 460 주제로 실시되었습니다
  • 피어 리뷰 저널에 발표된 HairMax에 대한 주요 임상 연구
  • 연구 결과 HairMax LaserComb FDA 510 (K) 제출을 지원하는 데 사용
  • HairMax 머리 손실 및 사용자의 93 %에 추진 머리카락 성장을 치료
  • 더 심각한 부작용도 HairMax 치료에서보고되지
  • 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
 

2001 년 이후 HairMax 실시 일곱 임상 연구들이 있었다. 2010 년, 연구 2는 남성에서 실시되었고 2 여성에서 실시되었다.



임상 결과


HairMax LaserComb ® 레이저 머리 치료 그룹의 과목이 있었다

  • 컨트롤 그룹에있는 과목 이상의 의미 터미널 머리 수를 크게 더 향상시킬 수 있습니다.
  • 컨트롤 그룹에있는 과목보다 머리카락의 두께와 충만의 훨씬 더 주관적 평가.
  • 제목은 레이저 탈모 치료의 심각한 불리한 사건을 경험하지 않습니다.
  • 불리한 이벤트 프로파일 HairMax 및 제어 그룹 사이에 유사한했다.

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

HairMax LaserComb 사용자 ® 레이저 헤어 성장 치료 *는 다음과 같은 주관적인 혜택의 일부 또는 전부를 받았습니다 :


  • 헤어 낙진의 상당한 감소.
  • 일부 사용자는 치료를 시작하면 telogen 낙진에 초기 증가를 경험하지만,이 기간 이후에, 새로운 anagen 성장이 관찰되었다.
  • 머리 성장의 증가 속도.
  • 머리보다 관리.
  • 머리카락 전체 나은 품질과 상태.

HairMax LaserComb clinical study before and after photo - Female

HairMax LaserComb clinical study before and after photo -Male


위에 표시된 사진은 실제 HairMax LaserComb 사용자 있지만 장치가 반드시 경험하게 될 것입니다 사용 결과 모두를 대변하기위한 수 없습니다. 자격을 갖춘 과목 stereotactic 장치를 사용하여 각 방문에 글로벌 이미지를 기록했다.

비 Vellus 헤어 밀도 매크로 이미지

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. 

취소 retouched 매크로 이미지가 표시되며 머리 성장 밀도에서 20 %의 증가를 증명과 함께 아래의 이미지에 해당합니다.

 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
 
 promotion of hair growth through changes in hair count
 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

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.
 

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®.
 
고객 만족은 기본 중요
      임상 헤어 성장 *을 홍보하기 위해 입증된
      이상 90 % 사용자 만족도가 보도
      미국의 특허 및 제조
      ISO 품질 보증
      더 나은 사업 국 자랑 회원
 

* HairMax 고급 7, 럭스 9, 전문가 12 모델은 Androgenetic 탈모증을 치료하는 표시, 및 머리카락 성장을 촉진 아르남성누가 V로 및 IIa의 Norwood 해밀턴 분류를여성사람이 루드비히 (아버님께 구원) I - 4, II - 1, II - 2, 또는 탈모 정​​면 패턴과 모두 피츠 패 트릭의 피부 타입 제가 IV해야합니다.