Key Clinical Study
The results of the key clinical study performed with the HairMax LaserComb
which led to FDA clearance was published in the May 2009 Issue of
Clinical Drug Investigation. The article entitled, HairMax LaserComb
Phototherapy Device in the Treatment of Male Androgenetic Alopecia, is
indexed as Clin Drug Invest 2009: 29 (5): 283-292 in most of
the biomedical databases such as MEDLINE, EMBASE/Excerpta Medica,
The study was designed to support a 510K submission to the FDA and was subjected to an IRB approval and conducted in accordance with GCP (Good Clinical Practices) as outlined by the FDA. The objectives of the study in males were to assess the following:
The study was designed as a multi-centered, double- blinded, randomized sham-device controlled trial conducted at four sites in the United States. Subjects were instructed to use the laser hair growth treatment device three times per week on non-consecutive days, 10-15 minutes per treatment for a total of 26 weeks. Hair density measurements were performed at baseline immediately prior to randomization and again at 26 weeks. Additional clinical visits were scheduled at 8 and 16 weeks to monitor the laser hair loss treatment progress and overall hair growth.
Qualified subjects had global images recorded at each visit using a stereotactic device. The global images above correspond with the un-retouched Macro images below and demonstrate 21% increase in hair growth density.
Non-Vellus Hair Density Macro Images
At baseline, a circle approximately 1 inch in diameter, positioned in the transition zone of the scalp, was identified as the site for hair clipping and tattooing. Within this site was the target area for the hair density evaluation during the laser hair growth treatment. Subjects were evaluated at baseline, week 8, week 16 and week 26. Digital images captured by FUJI S2 were taken of the target site within the clipped area following the site preparation. A 19 inch monitor was used for blinded evaluation.
Population and Demographics
The study population included males between the ages of 30 and 60 years with a diagnosis of Androgenetic Alopecia who had been experiencing active hair loss within the last 12 months. The inclusion criteria required a Norwood- Hamilton classification of IIa to V and Fitzpatrick skin types I to IV. All subjects were randomized for laser hair loss treatment analysis. A biostatistician calculated the study to be of a proper size to gauge statistically significant results of hair growth and hair density.
Lexington limited the skin types for the laser hair growth treatment study to Fitzpatrick I to IV to facilitate the hair counting process. It is difficult to count dark hairs on dark skin and therefore the darker Fitzpatrick skin types (V and VI) were not included in the study.
After diagnosing the scalp for Androgenetic Alopecia and exclusion of other dermatological conditions, subjects were randomized with either our active laser hair loss treatment device, or sham device. Subjects were then photographed for global evaluation and the target site of the scalp was identified and tattooed for baseline density. Subjects were then provided a device without usage instructions from the investigator per the protocol for OTC use. Subjects returned to the clinic at 8 and 16 weeks with a final visit at week 26 for clinical evaluation of hair density and hair growth.
Subjects in the HairMax LaserCombÂ® laser hair treatment group had significantly greater increase in mean terminal hair density than subjects in the sham group (p<0.0001). Subjects in the HairMax LaserCombÂ® group also had significantly better subjective assessments of overall hair growth than subjects in the sham group (p=0.010). No subject experienced a serious adverse event from the laser hair loss treatment and the adverse event profiles were similar between the two treatment groups.
(The clinical trial to assess the efficacy of the HairMax LaserCombÂ® laser hair growth treatment in females was just completed and will be reported on at a later date).
Users of the HairMax LaserCombÂ®
laser hair growth treatment received some or all of the following subjective