Clinical studies were performed under an FDA reviewed protocol at one of America’s leading research centers to qualify and quantify the efficacies of the LaserComb as a medical device for use in treating Alopecia (hair loss). Both male and female 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 the 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 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.
Each month, the patient would return to the clinic to have the study areas clipped, new photographs taken, and new hair counts recorded.
The clinical data we submitted was statically significant. These numbers are significantly better than any other product approved to date for hair regrowth.