HairMax LaserComb Advanced 7, Руководство пользователя

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CLINICAL DATA
The results of the key clinical study performed with the HairMax LaserComb
led to US FDA Clearance to market in January 2007. This was considered a
landmark event in the treatment of Androgenetic Alopecia. These clinical
results were published in
Peer Reviewed Journal
“HairMax LaserComb
Phototherapy Device in the Treatment of Male Androgenetic Alopecia*”.
Study Objectives
The study was conducted to support the FDA 510(k) submission and was
subjected to an Investigational Review Board (IRB) approval and conducted in
accordance with GCP (Good Clinical Practices). The objectives of the study
were to assess the following:
- Promotion of hair growth through changes in hair density
- Cessation of hair loss
- Overall scalp health
- Safety
Study Design
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, for a total of 26 weeks. Hair
density measurements were performed at baseline, immediately prior to
randomization and again at 26 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 within the last 12 months. The inclusion criteria required a Norwood-
Hamilton Classification of IIa to V and Fitzpatrick Skin Type Classification of I
to IV.
Clinical Results
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.
*Clin Drug Invest 2009: 29 (5): 283-292