HairMax LaserBand 82 User Manual

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HairMax LaserBand 82 User Manual Manual pdf 10 page image

SUMMARY OF CLINICAL STUDY IN WOMEN8SUMMARY OF CLINICAL STUDY IN WOMENA clinical study was conducted at multiple locations in the United States. All participants in the study werefemales, diagnosed with Androgenetic Alopecia, which includes hereditary hair loss, and had light to mediumskin tones. Subjects were divided into two groups. One group used the HairMax and the other group used acontrol device. The control device looked and sounded like the HairMax, but did not include a laser light. TheClinical studies adhered to all GCP (Good Clinical Practice) guidelines, were approved by an IRB (InstitutionalReview 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 were counted at Week 1,Week 16 and Week 26.Results at 26 weeks showed that over 90% of the women sawincreases in hair counts.*No subjects in the study experienced any serious adverse events.In fact, the number and types of adverse events were similar inthe HairMax and control groups.Hair Count ChangeIn the clinical study, after 26 weeks of treatment with the HairMaxand a control device, the following increases in hair countwere found.*Based on a minimum of 5 new hairs per square centimeter/32 new hairs per square inch being observed at the follow up visit20.5Hairs/cm2132.2Hairs/in22.7Hairs/cm217.4Hairs/in2LIT-UMLB82G-04-0718.qxp_Layout 1 copy 7/17/18 4:49 PM Page 7