Clinical Study Results Leading to FDA Clearance

The most demonstrative study relating to the efficacy of the HairMax LaserComb was the landmark clinical trial conducted in 2005.

The most recent study affirming the positive benefits of using the HairMax was completed in 2005 and culminated in the FDA’s clearance of the product to “Promote hair growth in males with Androgenetic Alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.”

Design
The study was designed as a multi-center, randomized sham-device controlled trial. In simple terms, neither the subjects nor the researchers knew who was using “real” devices and who was not. The purpose of this type of study is to be able to render the most un-biased analysis of results possible.

Trial subjects were to use the device three times per week on non consecutive days for a total of 26 weeks. The study population included only males.

Assessment of Efficacy
Using a microscopic analysis, hair counts were measured at the beginning of the trial and then compared to the measurements taken at the end of the study.

Results


Subjects using the HairMax LaserComb had significantly greater increases in hairs per square centimeter. The results concluded that subjects in the active group grew an average of 19.8 hairs, whereas subjects in the sham group lost 7.6 hairs. Also significant was that no subjects experienced any serious unwanted adverse event during the course of treatment. This landmark study has helped place the HairMax at the forefront of emerging hair loss treatment technologies, and is demonstrative of the types of benefits you can expect from your treatment with the HairMax.

Previous Studies in Low Level Laser Therapy

Professor Pekka J. Pontinen (1996)

One of the pioneers of LLLT in Scandinavia, Professor Pontinen generates thorough theoretical and practical studies on how to apply low level laser therapy in the treatment of chronic conditions, particularly musculoskeletal and myofascial pain and dysfunction, vascular disturbances, ulcer treatment and wound healing.

He also established the beneficial effect of Laser Hair Care (registered trademark) on scalp blood flow and published his results in 1996.

In his placebo controlled study he showed that LLLT increased scalp blood flow by 54% while the placebo’s scalp blood flow decreased by 36%.

This study is a clear indicator that LLLT acts as a definitive catalyst in increasing blood flow to the scalp and, as hypothesized by the makers of the HairMax LaserComb, helps grow hair as a result.

Published Scholarly Journal Article, International Journal of Cosmetic Surgery and Aesthetic Dermatology (2003)

This astounding study was the first independently conducted inquiry confirming the efficacy of LLLT using a HairMax LaserComb to stimulate hair growth and increase tensile strength 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.

Needless to say, the positive results rivaled that of our most recent FDA submitted clinical study. 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, but both sexes and all areas of the scalp (vertex, temporal and frontal) demonstrated significant improvement.

Additionally, hair tensile strength increased 78.9% when all temporal and vertex patients were considered. As with the hair counts, the tensile tests showed the maximum improvements were in the vertex area in males.