The use of phototherapy, the science behind the HairMax® LaserComb, has a long and substantial history.
Archaeologists have found that as early as 1550 BC Egyptian papyri detailed the use of phototherapy as a treatment for many conditions including a number of dermatological disorders.
In 1903, the second Nobel Prize in Medicine (physiology) was awarded to Niels Ryberg Finsen M.D., in recognition of his contribution to the treatment of diseases with concentrated light energy, or "phototherapy." It was this recognition that opened new avenues for medical science, and led to similar significant experimentation throughout the 20th century, including those which would later lead to the creation of the HairMax LaserComb.
Studies in Low Level Light Therapy (LLLT)
Low Level laser therapy has been used in attempts to regrow hair and prevent hair loss since the 1950’s. Below is a list of abstracts from various studies on this topic.
The studies are arranged beginning with the oldest and culminating in the landmark HairMax LaserComb clinical study which led to the FDA’s clearance to market of the device to promote hair growth in males with certain classes of Androgenetic Alopecia.
Professor Andre Mester (1964)
In 1964, Hungarian Professor Andre Mester began studying the use of low-power laser energy in biological systems. He observed that low-energy laser exposure had a stimulating effect on the biological system, while high-energy laser exposure had an inhibitory effect. He found that diabetic sores which would otherwise remain chronic, were healed. But most importantly, he discovered accelerated hair growth and thickening of the hair in the treated areas.
USA Study (2003)
This study was the first independently conducted inquiry confirming the efficacy of LLLT using a HairMax LaserComb to stimulate hair growth in subjects with Androgenetic Alopecia.
Thirty-five patients, 28 males and 7 females, all diagnosed with Androgenetic Alopecia, underwent treatment with a HairMax LaserComb for a six-month period.
A total of 93.5% of patients experienced increased hair counts when the results of all temporal and vertex patients were considered. In general, males treated in the vertex area showed the greatest gains, and all areas of the scalp (vertex, temporal and frontal) demonstrated significant improvement.
FDA Clinical Study Results (2005)
The clinical study that supported the 510K submission to the FDA on the efficacy of the HairMax LaserComb was submitted in January 2006. It led to the FDA Clearance to market the device in January 2007 with the official indication to help promote hair growth in certain classes of Androgenetic Alopecia.
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.
For detailed results of this study, Please Click Here
Clinical Studies Results (2009/2010)
Four clinical studies that supported 510(k) submissions to the FDA on the efficacy of the HairMax LaserComb were submitted in 2010. These led the FDA Clearance to1) market three new devices of the HairMax in males and 2) clearance for marketing for the treatment of AGA in females.
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