Efficacy of a comprehensive serum in Japanese subjects with moderate to severe facial hyperpigmentation

        A double-blind, placebo-regimen controlled clinical study was conducted to assess the efficacy and tolerability of a novel comprehensive HQ-free and retinol-free serum (LYT2) in Japanese subjects presenting with moderate to severe facial hyperpigmentation. Subjects were randomized 2:1 to receive LYT2 plus a sunscreen placebo regimen (cleanser, moisturizer, and broad spectrum sunscreen SPF 30) or only the sunscreen placebo regimen. Subjects in the LYT2 group applied the serum twice daily after cleansing for eight weeks. Both groups used the cleanser and moisturizer twice daily, and applied the sunscreen in the morning and as needed throughout the day. Thirty-five female and male subjects aged 37-67 years completed the twelve-week study (LYT2 n = 23; sunscreen placebo regimen n = 12). Clinical assessments for overall hyperpigmentation and skin tone evenness by the blinded investigator and standardized digital photography were conducted at all visits (baseline and weeks 4, 8, and 12). Subjects treated with LYT2 showed early significant reductions in both mean overall hyperpigmentation and skin tone evenness scores at week 4, with continuing significant reductions through week 12 (all P ≤ .02 compared to baseline; Wilcoxon signed-rank test). Subjects in the sunscreen placebo regimen did not show significant improvements until week 8 (for overall hyperpigmentation) or until week 12 (for skin tone evenness). LYT2 showed significantly greater improvements in skin tone evenness scores compared to the sunscreen placebo regimen at weeks 4 and 12 (all P ≤ .03 treatment comparisons; Wilcoxon ranked-sum test). Standardized digital photographs support the overall improvements observed by the investigator. Both treatments were well-tolerated with mean tolerability scores remaining mild or below throughout the study duration. Assessing the efficacy of product in a variety of ethnicities is important due to innate differences in melanin biology. Results from this study support the efficacy and tolerability of this novel comprehensive serum in improving the appearance of facial hyperpigmentation in Japanese subjects.
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