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SUMMARY OF CLINICAL STUDY IN WOMEN
A clinical study was conducted at multiple locations in the United States. All participants in the study were females, diagnosed with Androgenetic
Alopecia, which includes hereditary hair loss, and had light to medium skin tones. Subjects were divided into two groups. One group used the
Laser Comb and the other group used a Control Device. The Control Device looked and sounded like the Laser Comb, 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 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 area was counted at Week 1, Week 16 and Week 26.
Results at 26 weeks showed that over 90% of the women saw increases in hair
counts (based on a minimum of 32 new hairs per square inch (6.45 square cm)
being observed at the follow up visit).
No subjects in the study experienced any serious adverse events. In fact, the
number and types of adverse events were similar in the Laser Comb and control
groups.
Hair Count Change
In the clinical study, after 26 weeks of treatment with the Laser Comb and a
Control Device, the following increases in hair count were found.
Control Device
Hair/in2
Hair/in2
Mean Terminal Hair Count Changes
From Baseline in FEMALES
26 Weeks
Control Device
Hair/in2
Hair/in2
Laser Comb
