HairMax LaserComb Research
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- 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 - clave del estudio HairMax clínicos demostraron la eficacia en las mujeres
- 2010 - Los estudios clínicos demostraron la eficacia en los hombres con 3 nuevos modelos
- 2005 estudios clínicos y científicos clave con el HairMax demostrado su eficacia en los hombres
- 2003 - first HairMax IRB study showed 84.2% success in hair growth and over 45% hair count increase
- 2002 - HairMax estudio independiente demostró 78,9% de aumento en resistencia a la tracción y el 93,5% de aumento en los recuentos de pelo.
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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.
 Our 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.
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2010 - Estudio clínico clave en apoyo de 510 (k) La presentación a la FDA y la remoción subsiguiente al mercado en 2011
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Un estudio doble ciego, controlado por el dispositivo estudio clínico se llevó a cabo en centros de investigación que lleva a calificar y cuantificar la eficacia de la HairMax como un dispositivo médico para uso en el tratamiento de la alopecia androgenética (caída del cabello) en las mujeres. Los pacientes, con edades de entre 25 y 60, fueron incluidos en un período de seis meses de evaluación. Recuentos de pelo se midieron al inicio del estudio, a las 16 semanas y en la última visita a las 26 semanas. Además, los sujetos del grupo HairMax informó un aumento significativamente mayor en el grosor del pelo y la densidad.
Al final del período de seis meses, el 100% de los sujetos en el estudio mostraron un crecimiento de cabello nuevo éxito con un incremento promedio del recuento capilar en todos los pacientes de más de 20%. Estos números médica y científicamente significativos.
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2009 - Evaluation of the Activity of Laser Doses on Ex-Vivo Hair Growth
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Los resultados de un estudio comparativo de la elongación del pelo en un medio especial de longitudes de onda de láser diferentes en comparación con los no expuestos a la energía del láser se llevó a cabo. Los resultados después de 10 días de exposición diaria a las diferentes longitudes de onda demostró que todo el cabello alargado frente a los pelos de control que no mostró elongación.
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2005 - Key Clinical Study in Support of 510(k) Submission to the FDA and Subsequent Clearance to Market in 2007
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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
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2003 - First IRB Clinical Study
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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.
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| 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.
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Response criteria
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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. |
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Statistical Significance
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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.
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Charts showing the increases in hair growth in the
frontal & vertex sites for Males |
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2002 - Study
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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)
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Initial Studies in Australia
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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. |
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| 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 |
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* El HairMax Avanzada 7, Lux 9, y los modelos Professional 12 se indican para el tratamiento de la alopecia androgenética, y promover el crecimiento del cabello enlos hombresque han Norwood Hamilton Clasificaciones de IIa a V y enmujeresque han Ludwig (Savin) I-4, II-1, II-2, o los patrones de pérdida de cabello frontal y que ambos tienen tipos de piel Fitzpatrick I a IV.
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