2005 – Key Clinical Study in Support of 510(k) Submission to the FDA and Subsequent Clearance to Market in 2007*
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.
2003 – First IRB Clinical Study
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. The 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 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.
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.
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.
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.
Charts showing the increases in hair growth in the frontal & vertex sites for Males
2002 – Tensil Strength And Hair Counts
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.
Initial Studies in Australia
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.
This experimental study showed that laser energy applied to hair follicles ex-vivo stimulated elongation of hair.
Please click here to read all about this landmark study.