HairMax LaserComb - Information for Healthcare Professionals

Clinical Study

Summary:

Pivotal multi-center, double blind, sham device controlled study
Subjects used HairMax 3 times a week for 10-15 minutes per treatment
Males 30 – 60 years of age
Norwood Hamilton IIa-V, Fitzpatrick Skin Type I – IV
21% increase in hair density
Significantly greater increase in mean terminal hair density vs. placebo (p<0.0001)
No serious side effects reported

Information about Lexington's Pivotal Multi-Center Double Blind, Sham-Device Controlled Clinical Study

Figure 1: Mean Baseline Change at 26 Weeks in Terminal Hair Density (hairs/cm2).

Subjects in the HairMax® LaserComb treatment group had significantly greater increase in mean terminal hair density than subjects in the placebo group (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.

Clinical Results

The results of the key clinical study performed with the HairMax LaserComb which led to FDA Clearance to market 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, etc.

Study Objectives

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
safety

Study Design

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.

Methods

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.

Global Images

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 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.

(Six months image shows evidence of ink spread)

The HairMax LaserComb® is the only medical hair growth device on the market with FDA marketing clearance for the treatment of certain classes of Androgenetic Alopecia in males.