Low-level light therapy using a helmet-type device for the treatment of androgenetic alopecia: A 16-week, multicenter, randomized, double-blind, sham device-controlled trial.

INTRODUCTION: Androgenetic alopecia is the most common form of hair loss in both sexes. In recent studies, low-level light therapy (LLLT) has been established as an effective treatment for alopecia. The purpose of this study was to evaluate the safety and efficacy of LLLT using a new helmet-type device for the treatment of androgenetic alopecia. METHOD: A randomized, sham device-controlled, double-blind clinical trial was conducted at 2 institutions. Sixty participants diagnosed with androgenetic alopecia aged from 19 to 65 years were recruited. LLLT was performed through a helmet-type device that emitted light with a mean output power of 2.36 mW/cm at a wavelength of 655 nm. Participants were divided into 2 groups, which respectively used the experimental device and a sham device. After tattooing at the central point of the vertex, phototrichograms at that point were obtained at 0, 8, and 16 weeks. The primary endpoint of the study was the difference in the rate of change of hair density between the test group and the control group. RESULTS: Comparing the results at baseline and week 16, the experimental group showed an increase in hair density of 41.90 hairs/cm and an increase in hair thickness of 7.50 µm, whereas the control group showed an increase of 0.72 hairs/cm and a decrease of 15.03 µm, respectively (P < .001). No adverse events or side effects occurred. CONCLUSION: LLLT showed a significant effect on increasing hair density in patients with androgenetic alopecia. LLLT could be a safe and effective treatment for androgenetic alopecia in both sexes.