7
Clinical studies 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 medium skin tones. Subjects were divided into two groups, Laser Comb Group
and a Control Group. The Control Device looked and sounded like the Laser Comb 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 was counted at week 1, week 16 and week 26.
Results at the 26-week visit showed that over 93% of the men saw an increase
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 devices
versus the Control Device, the following increases in hair count were found.
SUMMARY OF CLINICAL STUDY IN MEN
Control Device
Laser Comb
Hair/in2
Hair/in2
Mean Terminal Hair Count Changes
From Baseline in MALES
26 Weeks
