LLLT CLINICAL STUDIES
The following is a summary of twin studies conducted on Male and Female Subjects utilizing the same methods of treatment and control.
The Growth of Human Scalp Hair in Males and Females Using Visible Red Light Laser and LED Sources
Twin double-blind randomized controlled trials were undertaken to define the safety and physiologic effects of LLLT on males and females with androgenic alopecia. Methods: Forty-seven females (18-60 years old, Fitzpatrick I-IV, and Ludwig–Savin Baldness Scale I-2, I-3, I-4, II-1, II-2 baldness patterns) and 44 males (18-48 years old, Fitzpatrick I-IV and Hamilton Norwood Hair Los Scale IIa-V) were recruited. A transition zone scalp site was selected; and hairs were trimmed to 3mm height; the area was tattooed and photographed. The active group received a “TOPHAT655” unit containing 21, 5mW diode lasers (655 _5 nm) and 30 LEDS (655 _20 nm), in a bicycle helmet-like apparatus. The placebo group unit appeared identical, containing incandescent red lights. Patients treated at home every other day_16 weeks (60 treatments, 67 J/cm2 irradiance/ 25-minute treatment, 2.9 J dose), with follow up and photography at 16 weeks. A masked 2.85 cm2 photographic area was evaluated by another blinded investigator.
The primary endpoint was the percent increase in hair counts from baseline.
The studies were blinded multicenter studies. The study subjects were allocated to Active Treatment or Sham on a 1:1 basis at each of four study sites. A total of 91 patients were enrolled in the studies and completed baseline screening and photography. However, eight subjects withdrew from the study prior to the initiation of
treatment. Thus, there were 45 active treatment and 38 sham subjects available for analysis at the end of the studies, after 16 weeks of treatment. There were no reported side effects or adverse events reported by any subject or site at any time during the studies.
The LLLT device that was used was called the TOPHAT 655 (iGrow Hair Growth System) It is a low-level diode laser system, operating at 655 nanometers, containing 21 laser diodes and 30 LED lasers, affixed in a wearable helmet structure. The subject placed the unit upon their head and pressed a button, which commenced a 25-minute session. The lasers and LED automatically shut off after the treatment session was complete. There was no pre or post treatment care required, only that the subject’s hair was clean and did not contain spray or gel fixative agents. No safety eyewear was required during the treatment session. The subjects were all required to use the helmet four times per week for 25 minutes throughout the 16-week period. Informed consent was obtained from each subject to verify that he or she met the inclusion and exclusion criteria for the study. History and physical examinations were conducted. An area of scalp was selected in a transition zone at the vertex of the scalp at a site determined by the investigator. The hairs within the selected site were trimmed to a maximum height of 3mm in area that was approximately 2.5cm in diameter. The area was marked with a medical tattooing green ink using aseptic technique.
Hair Counts and Photography
Photographs of the selected scalp site were taken prior to any treatment (baseline), and the same site was again
photographed after the final treatment had been performed (post-treatment). Examples of baseline (pre treatment) and final (post treatment) images are presented in Figures 1 and 2 (See Below). Figure 1 demonstrates the results for typical patients in the placebo or sham group. Note that there is only a slight change present in the images taken at 16 weeks as compared to the baseline images. Figure 2 demonstrates baseline and final images for typical subjects in the active treatment group. A significant increase in the number of terminal hairs present is evident in the 16-week photographs, compared to baseline. The diameter of the hairs present in the sample areas was not measured.
SUMMARY OF RESULTS
These studies demonstrate that that low-level laser (light) treatment of the scalp every other day for 16 weeks
using the TOPHAT 655 (iGROW HAIR GROWTH SYSTEM ) device is a safe and effective treatment for androgenic alopecia in healthy men and women. Subjects receiving LLLT at 655nm achieved an average 36% increase in hair counts, as compared to sham treated control patients in this multi-center RCT.