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

초록

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, approximate to 780 nm) photothermal actuation. Under brief LED illumination, the GNRs deliver a mild, eyelid-safe thermal micro-dose (similar to 41 degrees C) that accelerates tip dissolution and enhances short-range transport without increasing needle length. Tissue-mimicking phantoms show heat-augmented dye advance (approximate to 5.1 mm vs. approximate to 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 year) with thrice-weekly use for four weeks, under-eye PRIMOS average roughness (R-a) improved by 16.3% at week 4 (p < 0.001), and periorbital brightness (VISIA-CR L*) increased by similar to 1.5-2.0%. A with-/without-NIR comparison at the crow's-feet favored actuation (similar to 14.1% vs. similar to 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.

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