T.-M. Chang, C.-C. Wu, H.-C. Huang, J.-Y. Lu, Y.-S. Chen, P.-L. Kao, W.-H. Tang, W.-J. Hsieh, L. T.-C. Liu, I. Percec, C. Chen, T.-Y. Kuo
Scalp dysregulation and hair shedding are common cosmetic concerns, driving an increasing demand for non-pharmaceutical interventions, including plant-derived extracellular vesicles (EV) and growth factors. This randomized controlled trial evaluated the efficacy of topical formulations in 60 healthy adults over a 56-day period, monitoring scalp and hair parameters at Days 14, 28, 42, and 56 relative to baseline (Day 0). Group A: placebo; Group B: base (placebo containing 0.1% caffeine and panthenol); Group C: base + recombinant Fc-fusion long-acting insulin-like growth factor-1 (rIGF-1) and fibroblast growth factor-7 (rFGF-7); Group D: base + Centella asiatica (C. asiatica) + ginger EVs; and Group E: base + rIGF-1, rFGF-7, and C. asiatica + ginger EVs. Group E demonstrated rapid onset and significant superiority over the control and other treatment groups across all parameters. In scalp regulation, Group E achieved a highly significant, time-dependent reduction in excess sebum, reaching a 67% decrease by Day 56. Hair growth kinetics were significantly accelerated in Group E, with a mean cumulative length increase approaching 3.9 cm by Day 56, driven by a surge in mean weekly growth velocity to 1.4 cm/week. Group E also demonstrated the highest improvements in hair thickness (19 m) and hair density (17% increase) by Day 56. Finally, hair shedding was reduced by almost half by Day 56 in Group E. These results demonstrate that the formulation delivers a clinically superior non-pharmaceutical intervention for advanced hair and scalp revitalization.