HairMax FDA Clinical Trial
Information about Lexington's Multi-Center Double Blind, Sham-Device Controlled Clinical Study
The study was designed to support the 510K submission to the FDA and was subjected to an IRB approval and complied in accordance with GCP (Good Clinical Practices). The objectives of the study in males were to assess the following:
- promotion of hair growth through changes in hair density
- cessation of hair loss
- scalp overall health
(The clinical trial to assess the efficacy of the HairMax LaserComb in females was just completed and will be reported on at a later date).
The study was designed as a multi-center, randomized, sham-device controlled trial conducted at four sites in the United States. Subjects were to use the device three times per week on non-consecutive days 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.
Subject 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 with the last 12 months. The inclusion criteria required a Norwood-Hamilton classification or IIa to V and Fitzpatrick Skin Type I to IV. All subjects were randomized. A biostatistician calculated the study to be of a proper size to gauge statistically significant results.
After an assessment of the scalp for androgenetic alopecia and exclusion of other dermatological conditions, subjects were randomized with either active or sham devices. Subjects were then photographed for global evaluation, had the target site of the scalp identified and tattooed for baseline density and were given the device without investigation usage instructions per protocol for OTC use. Subjects returned to the clinic at 8 and 16 weeks with a final visit at week 26 for clinical evaluation.
Subjects in the HairMax LaserComb treatment group had significantly greater increase in mean terminal hair density (19.80 cm2) than subjects in the placebo group (-7.60 cm2) (p<0.0001). Subjects in the HairMax LaserComb group also had significantly better subjective assessment of overall hair regrowth than subject in the placebo group (p=0.010). No subject experienced a serious adverse event and the adverse event profiles were similar between the two treatment groups.
Qualified subjects had global images recorded at each visit using a stereotactic device. The global images above correspond with the unretouched Macro images below and demonstrate 21% increase in hair 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. 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.
In January 2007, the HairMax LaserComb® became the first ever medical laser device to receive FDA clearance for the following indications and uses:
"Promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV."
The HairMax LaserComb device offers a non-topical, drug free treatment option – something that makes the HairMax highly distinct from the two other clinically proven medications.
Why FDA Efficacy Trials?
Hand-in-hand with Lexington International’s unwavering commitment to customer satisfaction, was the pursuit of this costly clinical efficacy trial to help quantify the effectiveness of the HairMax LaserComb and to prove that it truly works to promote hair growth in males with Androgenetic Alopecia.
To put it simply, we know about the countless devices on the market that promise to re-grow hair, but end up having little or no effectiveness.
For this reason, we vigorously pursued FDA clearance. With this milestone accomplishment, we can now assure you and your patient of our devices' effectiveness.