An analysis undertaken to assess the safety and
efficacy of the HairMax LaserComb from 6 double blind clinical studies with 460
subjects found that no serious side effects occurred in any of these studies
which proved the efficacy of the device in treating androgenetic alopecia
(hereditary hair loss) in men and women.
This analysis combined with the fact that there have never been any reports of
serious side effects occurring in the over 10 years the HairMax has been on the
market, demonstrates that the HairMax LaserComb has an excellent risk to benefit
profile.
Treating hereditary hair loss in men and women requires serious considerations
regarding not only efficacy, but safety. Lexington Int'l has recently completed
an analysis of the efficacy and safety of the HairMax LaserComb in 6
double-blind, device clinical trials of androgenetic alopecia with 460 male and
female subjects.
The first part of the analysis demonstrated the efficacy of the device.
Presently, there are 2 drugs with FDA approval, and 1 non-drug product with FDA
Clearance, the HairMax LaserComb® laser phototherapy medical device for treating
the condition. In each and every study, conclusive proof that the HairMax is
effective in treating androgenetic alopecia (hereditary hair loss) was found,
and that these results are predictable, consistent, and comparable to the drugs
approved for treating this condition.
The second part of the analysis was to assess the safety of the subjects in the
clinical studies..The results of the analysis of all 6 studies showed that no
serious side effects occurred and that any side effects reported were similar to
those reported with the control (placebo) device.
Link to description of the clinical trials:
http://clinicaltrials.gov/ct2/results?term=hairmax
Since hair loss is an aesthetic condition, the risk to benefit profile has to be
considered before using a product for treatment. The HairMax has been marketed
since 2001 and has been used successfully by hundreds of thousands of
individuals to treat their hair loss. Since that time, there has never been any
reports of serious side effects occurring. This combined with the analysis of
the safety and efficacy results from the 6 clinical trials yields an excellent
risk to benefit equation for the HairMax, making the device the obvious choice
of treatment for men and women suffering from hair loss.
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