Abstract
We developed and tested the safety and efficacy of a cosmetic device to improve dark circles using electrical muscle stimulation of the orbicularis oculi muscle. Overall, 18 participants (36 eyes) were studied. The following five items were evaluated before and after the intervention:(1) the Clinical Dark Circle Score using clinical findings and photographs, (2) transcutaneous oxygen partial pressure (TcPO2) on the lower eyelid, (3) thermography, (4) two-dimensional laser blood flowmetry, and (5) spectrophotometry. The mean score at baseline was 2.0±0.90 (mean±standard deviation), and that at the end of the study was 1.2±1.0 (Wilcoxon signed-rank sum test, p<0.0001), indicating a significant reduction. The spectrophotometer showed a significant decrease in a* and L* values before and after use (Wilcoxon signed-rank sum test, p<0.0001). There was also a weak negative correlation between the change in score and the change in blood flow and TcPO2 measured using a laser perfusion device (Spearman's rank correlation coefficient, r=-0.32 and -0.39, respectively). Stratified analysis of the baseline score showed a strong negative correlation between the change in score and the change in spectrophotometric a* in the subjects/group with mild periocular dark circles (Spearman's rank correlation coefficient, r=-0.46). Contrastingly, no correlation was observed for any of the measurements in the subjects/group with severe periocular dark circles. After 1 month, no device-related ophthalmic adverse events were observed in any of the participants. Electrical muscle stimulation could improve periocular dark circles, especially in the subjects/group with mild periocular dark circles, and was safe.
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