Tolerability, Acceptability, and Reproducibility of Topical STAR Particles in Human Subjects

The study evaluated the tolerability, acceptability, and reproducibility of STAR particles, which are microneedle protrusions applied topically to enhance skin permeability. Involving human subjects, the study found that a one-time application at pressures between 40 and 80 kPa resulted in skin microporation and erythema, with 83% of participants finding the application comfortable. Over 10 consecutive days of application at 80 kPa, skin microporation and erythema remained consistent, and comfort levels increased from 58% to 71%. Familiarity with STAR particles also rose, with 50% of subjects reporting no difference from other skin products. The study concludes that STAR particles are well tolerated, highly acceptable, and offer a safe, reliable method for enhancing drug delivery through the skin.