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The New HairMax LaserComb Lux 9Lexington has taken their clinically proven technology and x ncorporated it into a new sleek ergonomic design. And – it is battery powered. Now you have the freedom of movement as you treat your hair with the new HairMax Lux 9. The new model has the same effectiveness as the original FDA approved model. The battery circuitry has been designed to ensure that the laser energy will remain constant throughout the treatment cycle. If the battery weakens, the laser will shut off (not diminish) and alert the user that it is time to plug in or charge the batteries.
Included in PackageLimited Time Offer - Icludes free Activ8 Nutri-MX with 3.5% Minoxidil or Free Hairmax Hair Loss Vitamins. (More Info)One HairMax LaserComb Lux 9®Premium Leatherette Travel CaseWorldwide AC Power Adapter
110-240 VoltsUser ManualWarranty
Key Clinical Study
The results of the key clinical study performed with the HairMax LaserComb
which led to FDA clearance 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,
The 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:
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.
Qualified subjects had global images recorded at
each visit using a stereotactic device. The global images above correspond with
the un-retouched Macro images below and demonstrate 21% increase in hair growth
Density Macro Images
At baseline, a circle approximately 1 inch in
diameter, positioned in the transition zone of the scalp, was identified as the
site for hair clipping and tattooing. Within this site was the target area for
the hair density evaluation during the laser hair growth treatment. Subjects
were evaluated at baseline, week 8, week 16 and week 26. Digital images captured
by FUJI S2 were taken of the target site within the clipped area following the
site preparation. A 19 inch monitor was used for blinded evaluation.
Population and DemographicsThe study population included
males between the ages of 30 and 60 years with a diagnosis of Androgenetic
Alopecia who had been experiencing active hair loss within the last 12 months.
The inclusion criteria required a Norwood- Hamilton classification of IIa to V
and Fitzpatrick skin types I to IV. All subjects were randomized for laser hair
loss treatment analysis. A biostatistician calculated the study to be of a
proper size to gauge statistically significant results of hair growth and hair
density. Lexington limited the skin types for the laser hair growth
treatment study to Fitzpatrick I to IV to facilitate the hair counting process.
It is difficult to count dark hairs on dark skin and therefore the darker
Fitzpatrick skin types (V and VI) were not included in the study.
After diagnosing the scalp for
Androgenetic Alopecia and exclusion of other dermatological conditions, subjects
were randomized with either our active laser hair loss treatment device, or sham
device. Subjects were then photographed for global evaluation and the target
site of the scalp was identified and tattooed for baseline density. Subjects
were then provided a device without usage instructions from the investigator per
the protocol for OTC use. Subjects returned to the clinic at 8 and 16 weeks with
a final visit at week 26 for clinical evaluation of hair density and hair
Subjects in the HairMax LaserComb®
laser hair treatment group had significantly greater increase in mean terminal
hair density than subjects in the sham group (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 from the laser hair loss treatment and the
adverse event profiles were similar between the two treatment groups.
(The clinical trial to assess the
efficacy of the HairMax LaserComb® laser hair growth treatment in females was
just completed and will be reported on at a later date).
Users of the HairMax LaserComb®
laser hair growth treatment received some or all of the following subjective
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