Lasercomb
for men and women with hair loss
Study Objectives
The study was designed to support the 510K submission to the FDA and
was subjected to an IRB approval and complied in accordance with GCP
(Good Clinical Practices). 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
scalp overall health
safety
(The clinical trial to assess the efficacy of the HairMax LaserComb
in females was just completed and will be reported on at a later
date).
Study Design
The study was designed as a multi-center, randomized, sham-device
controlled trial conducted at four sites in the United States.
Subjects were to use the device three times per week on
non-consecutive days 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.
Subject Population and
Demographics
The 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 with the last 12 months. The inclusion
criteria required a Norwood-Hamilton classification or IIa to V and
Fitzpatrick Skin Type I to IV. All subjects were randomized. A
biostatistician calculated the study to be of a proper size to gauge
statistically significant results.
Methods
After an assessment of the scalp for androgenetic alopecia and
exclusion of other dermatological conditions, subjects were
randomized with either active or sham devices. Subjects were then
photographed for global evaluation, had the target site of the scalp
identified and tattooed for baseline density and were given the
device without investigation usage instructions per protocol for OTC
use. Subjects returned to the clinic at 8 and 16 weeks with a final
visit at week 26 for clinical evaluation.
Clinical Results
Subjects in the HairMax LaserComb treatment group had significantly
greater increase in mean terminal hair density (19.80 cm2) than
subjects in the placebo group (-7.60 cm2) (p<0.0001). Subjects in
the HairMax LaserComb group also had significantly better subjective
assessment of overall hair regrowth than subject in the placebo
group (p=0.010). No subject experienced a serious adverse event and
the adverse event profiles were similar between the two treatment
groups..
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Figure 1: Mean Baseline Change at 26 Weeks in Terminal Hair Density (hairs/cm2). |
Global Images
Qualified subjects had global images recorded at each visit using a
stereotactic device. The global images above correspond with the
unretouched Macro images below and demonstrate 21% increase in hair
density.
Non-Vellus Hair 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. 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.
FDA Clearance
In January 2007, the HairMax LaserComb® became the first ever
medical laser device to receive FDA clearance for the following
indications and uses:
"Promote hair growth in males with androgenetic alopecia who have
Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin
Types I to IV."
The HairMax LaserComb device offers a non-topical, drug free
treatment option – something that makes the HairMax highly distinct
from the two other clinically proven medications.
Why FDA Efficacy Trials?
Hand-in-hand with Lexington International’s unwavering commitment to
customer satisfaction, was the pursuit of this costly clinical
efficacy trial to help quantify the effectiveness of the HairMax
LaserComb and to prove that it truly works to promote hair growth in
males with Androgenetic Alopecia.
To put it simply, we know about the countless devices on the market
that promise to re-grow hair, but end up having little or no
effectiveness.
For this reason, we vigorously pursued FDA clearance. With this
milestone accomplishment, we can now assure you and your patient of
our devices' effectiveness.