HairMax FDA Clearance: A milestone in Hair Care, Hair Growth and Hair Science

In January 2007, the HairMax LaserComb® became the first medical laser device to receive FDA Clearance for the "Promotion of Hair Growth" in males. 

The FDA clearance of the HairMax LaserComb® has significant implications for the Hair Loss Treatment industry. Currently, there are only two other approved treatment modalities available, but with the addition of the HairMax, there is now a viable alternative to these methods. With the HairMax, no longer do you need to worry about ongoing expenses or deal with negative side effects.

Note that while the HairMax works well as a standalone treatment, it is possible to use it in conjunction with the other approved therapies of your choosing. Remember, fighting hair loss is an uphill battle and the FDA clearance of the HairMax* now makes you one step closer to winning your battle with hair loss.

The HairMax LaserComb is also a non-topical, drug free treatment option – something that makes the HairMax highly distinct from the other clinically proven products.

HairMax Studies and the FDA Clearance Process

After years of extensive research and randomized clinical studies, Lexington International submitted the results of its six-month, multi-center placebo controlled clinical trials in 2006. The data collected from the trials indicated that 93% of the participants, all males aged 30-60, had a mean increase of 19 terminal hairs/cm2 – a medically significant increase, and evidence that the HairMax is a viable treatment option for those wishing to avoid the use of drugs and/or topicals.

The studies also showed that there were no serious adverse effects in any of the trial participants.

FDA Clinical Study (2005)Study ObjectivesThe study was designed to support a 510K submission to the FDA and was subjected to an IRB approval and conducted in accordance with GCP (Good Clinical Practices) as outlined by the FDA. The objectives of the study in males were to assess the following:

 promotion of hair growth through changes in hair density
 cessation of hair loss
 overall scalp health
 safety

The study was designed as a multi-centered, double- blinded, randomized sham-device controlled trial conducted at four sites in the United States. Subjects were instructed to use the laser hair growth treatment device three times per week on non-consecutive days, 10-15 minutes per treatment for a total of 26 weeks. Hair density measurements were performed at baseline immediately prior to randomization and again at 26 weeks. Additional clinical visits were scheduled at 8 and 16 weeks to monitor the laser hair loss treatment progress and overall hair growth.

Subjects in the HairMax LaserComb® laser hair treatment group  had significantly greater increase in mean terminal hair density (19.80 cm2) than subjects in the sham group (-7.60 cm2) (p<0.0001). Subjects in the HairMax LaserComb® group also had significantly better subjective assessments of overall hair growth than subjects in the sham group (p=0.010). No subject experienced a serious adverse event to the laser hair loss treatment and the adverse event profiles were similar between the two treatment groups.

User Benefits

Users of the HairMax LaserComb® laser hair growth treatment received some or all of the following subjective benefits:

A substantial decrease in hair fallout.
Some users experienced an initial increase in telogen  fallout after starting  treatment, but after this period, new anagen growth was observed.
Increased speed of hair growth.
More manageability of the hair
Overall better quality and condition of hair

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