SUMMARY OF CLINICAL STUDY IN MEN
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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 brown
skin tones. Subjects were divided into two groups, LaserComb Group and a Control Group. The Control
Device looked and sounded like the LaserComb 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 (based on a minimum of 32 new
hairs per square inch 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 LaserComb and Control Groups.
Hair Count Change
In the clinical study, after 26 weeks of treatment with the
LaserComb devices versus the Control Device, the following
increases in hair count were found.
Summary of Contents for LaserComb Ultima 9
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