A Randomized Double-Blind Evaluation of a Novel Biotin and Silicon Ingredient Complex on the Hair and Skin of Healthy Women

Introduction: Age related changes in hair and skin impact quality of life. Interventions to mitigate these changes are of interest. Aim: To examine the safety and efficacy of LustrivaTM (a novel source of biotin and silicon) at a high or lower dose compared to placebo for impacts on hair and skin. Materials and Methods: In a randomized, double-blind study, 90 healthy female subjects with self-reported thinning hair who met Savin/Ludwig Scale criteria I-2 to II-1 by physician evaluation were randomized to one of three groups for 12 weeks (n=30/group): LustrivaTM High-Dose (LHD), LustrivaTM Low-Dose (LLD) or Placebo (PL). Hair quality and thickness measured by the TrichoScan HD testing system and skin parameters (facial wrinkles, fine lines, skin texture, skin color evenness, skin elasticity) measured by the Antera 3DTM System and the CutometerTM Dual MPA 580 system. Results: There was a significant increase in hair thickness measured by change in % vellus hair and % terminal hair and in the ratio of % vellus to terminal hair in LHD compared to PL at Week 3, maintained throughout the study (p=0.029). LHD had a significant decrease in facial wrinkles (12 Weeks) measured by a change in maximal wrinkle depth vs. PL (p=0.031). After 12 weeks compared to baseline LHD significantly improved facial wrinkle Maximum Depth, Indentation Index and Score, facial fine lines Indentation Index and Score, and facial texture Maximum Height, Roughness and Score (p<0.05), no change in PL. There were no changes for skin elasticity between groups. For some hair and skin parameters, LLD showed improvements less than LHD but that approached significance (p<0.1). All groups improved in subjective nail endpoints vs. baseline with no significant differences between groups. No adverse events reported. Conclusion: LHD significantly increased hair thickness and reduced facial wrinkle depth compared to placebo and performed better than the LLD in most parameters. Future studies are warranted.