Volu-Med HairMax LaserComb Premium, Руководство пользователя

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Makes hair appear thicker, fuller healthier
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Reduce shedding
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Makes hair shinier, more manageable
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Improve blood flow or circulation
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Energize or stimulate follicles
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Improves appearance of hair
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Energizes scalp
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Users experience more “good hair” days
III Hairmax Clinical trials
Here you will find a summary of the clinical trial which lead to the approval by the FDA. Full report is also
available.
Final Clinical Study Report
A Randomized, Double-Blind Clinical Trial to Evaluate
the Safety and Efficacy of the Hairmax LaserComb
for the Treatment of Androgenetic Alopecia in Males
Conclusions
The results of this study showed that the HairMax LaserComb
®
was effective in the promotion of hair growth
and in the cessation of hair loss in males and females diagnosed with androgenetic alopecia when treatment is
applied 10-15 minutes three non-concurring days a week (i.e. Monday, Wednesday, Friday) for 26 weeks. The
results also demonstrated that the LaserComb is safe in these subjects.
Study Objectives
The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb in the
promotion of hair growth and in the cessation of hair loss in males and females diagnosed with Androgenetic
alopecia.
Study Design
The study was designed as a multi center, randomized, placebo-controlled trial conducted at four sites in the
United States. Subjects who met all entry criteria were randomized in a 2:1 fashion to receive either the
HairMax LaserComb or an identical sham device that did not emit a laser. Subjects were to use the device
three times per week on non-concurring days for a total of 26 weeks. Hair density measurements were done at
baseline immediately prior to randomization and again at 26 weeks. Subjects who terminated prematurely
were to have had hair density measurements at their termination visit. Additional clinic visits were scheduled
at 8 and 16 weeks.
Subject Population and Demographics
The study population included males and females 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. They were also
required to have a Norwood-Hamilton classification of IIa to V (for males) or Ebling Rook I to III (for