Clinical Safety and Efficacy of Dual Wavelength Low-Level Light Therapy in Androgenetic Alopecia: A Double-Blind Randomized Controlled Study.

Background: The light-emitting diode cap being investigated is FDA cleared for the treatment of androgenetic alopecia (AGA).

Objective: Evaluating 3 versions of a red and blue light LED cap: (1) 625- and 660-nm red light, (2) 425-nm blue light, and (3) both 425-nm blue light and 625- and 660-nm red light against sham.

Patients and methods: Twenty-six-week, multicenter, randomized, controlled, double-blinded study. Adults aged 18 to 65 years with AGA were randomized to an active device or sham and underwent 10-minute treatments daily.

Results: One hundred sixty subjects were randomized. Ninety-one subjects were excluded for the per-protocol analysis. The per-protocol population included participants who completed 16 weeks of treatment, had no major protocol violations, and were at least 80% treatment compliant. Although the primary endpoint (mean change in non-vellus hair count from baseline to week 16) did not reach statistical significance in the individual study arms, in the pooled analysis (combining the 3 active study arms), there was a statistically significant (p = .033) difference versus sham. The pooled study cap group achieved 28.5 more hairs per cm2 when compared with sham.

Conclusion: The LED caps were well tolerated and increased hair density in patients with AGA.