Wearable near-infrared LED photothermal microneedle patch reduces periorbital wrinkles in a randomized pilot clinical trial

Abstract

Microneedle patches are typically passive, limiting control over dissolution kinetics and transdermal transport. Here we introduce a wearable, actively actuated microneedle system in which dissolving hyaluronic-acid tips penetrate the stratum corneum while a hydrocolloid backing embedded with hyaluronic-acid–gold-nanorod (HA–GNR) nanocomposites provides near-infrared (NIR, ≈780 nm) photothermal actuation. Under brief LED illumination, the GNRs deliver a mild, eyelid-safe thermal micro-dose (~41 °C) that accelerates tip dissolution and enhances short-range transport without increasing needle length. Tissue-mimicking phantoms show heat-augmented dye advance (≈5.1 mm vs ≈2.6 mm at 15 min), supporting a mechanism involving accelerated dissolution and enhanced localized transport driven by combined diffusion and micro-convective effects. In a monocentric, randomized, investigator-blinded pilot trial (n=20 women, 30–59 yr) with thrice-weekly use for four weeks, under-eye PRIMOS average roughness (Ra) improved by 16.3% at week 4 (p < 0.001), and periorbital brightness (VISIA-CR L*) increased by ~1.5–2.0%. A with-/without-NIR comparison at the crow’s-feet favored actuation (~14.1% vs ~1.9% improvement at week 4). No device-related adverse events were observed. By decoupling penetration from actuation through a plasmonic nanocomposite backing, this platform transforms dissolving microneedles into programmable, eyelid-compatible transdermal devices with human evidence, suggesting broad utility for gentle, controllable delivery at sensitive sites.