HairMax PowerFlex Laser202, User Manual

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8
Clinical studies on HairMax
®
technology were conducted at multiple locations in the
United States. Participants in the study were males diagnosed with Androgenetic alopecia,
which includes hereditary hair loss, and had light to brown skin tones.
Subjects were divided into two groups, active group and a control group. The control device looked and
sounded like the active device but did not include a laser light. The clinical studies adhered to all GCP
(Good Clinical Practice) guidelines, were approved by an IRB (Institutional Review Board) and listed on
www.clinicaltrials.gov.
During the 6 month clinical study, subjects treated their hair once per day, 3 times per week on non-
consecutive days. The number of thick, normal healthy hairs in the target zone were counted at Week 1,
Week 16 and Week 26.
Results at the 26 week visit showed that over 90% of the men saw an increase in hair counts.*
No subjects in the study experienced any serious adverse events. In fact, the number and types of
adverse events were similar in the active and control groups.
Hair Count Change
In the clinical study, after 26 weeks of treatment with the active device versus
the control device, the following increases in hair count were found.
*Based on a minimum of 5 new hairs per square centimeter/32 new hairs per square inch being observed at the follow up visit
SUMMAR
Y OF CLINICAL STUDY IN MEN
SUMMARY OF CLINICAL STUDY IN MEN
20.5
Hairs/cm2
132.2
Hairs/in2
2.7
Hairs/cm2
17.4
Hairs/in2
21.6
Hairs/cm2
139.3
Hairs/in2
4.3
Hairs/cm2
27.7
Hairs/in2
21.6
Hairs/cm2
139.3
Hairs/in2
4.3
Hairs/cm2
27.7
Hairs/in2