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.

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