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This comparative, controlled study demonstrates the positive biologic effect on hair regrowth of a pulsed electrical field administered according to a regularized treatment schedule over 36 weeks. Mean hair count comparisons within the groups significantly favor the treatment group, which exhibited a 66.1% hair count increase over baseline. The control group increase over baseline was 25.6%. It is notable also that 29 of the 30 treatment subjects (96.7%) exhibited regrowth or no further hair loss. The process is without side effects and untoward reactions. The rationale of this phenomenon is unclear but is considered to be due to an electrophysiologic effect on the quiescent hair follicle, similar to that documented with respect to bone fracture and soft tissue repair enhancement. The electrical pulse may cause increased cell mitosis through calcium influx, involving both the hair follicle sheath and dermal papilla cells.

These data represent a subset of data from the original 36-week study conducted by Maddin et al., which was in itself a preliminary study of a pulsed electrical stimulation device in male subjects alone. The extension phase of this study, which is summarized here, was undertaken to gather data on longer-term efficacy and safety and to study clinical effects in control subjects who were then switched to active treatment. Thirteen subjects had active treatment for 70 weeks, and 14 subjects were included in the crossover group, which had sham treatment for 36 weeks followed by active treatment for 30 additional weeks. On average, terminal hair counts increased from 82 to 276 in the active treatment group. Among those in the crossover group, a mild increase, from 124 to 160, was observed during the sham treatment period and a more notable increase, from 160 to 249, occurred during the subsequent active treatment period. The results presented here provide evidence of the efficacy and safety of this device during extended use; however, the generalizability of these findings is limited by the small subset of subjects for whom complete data are available.