Injectable Particulated Human Acellular Dermal Matrix Booster for Skin Restoration: An Integrated Randomized, Split-Face, Double-Blinded Clinical Trial and Preclinical Study

Abstract

Injectable skin boosters currently in use mainly provide short-lived volumization or depend on inflammation-mediated collagen stimulation, raising concerns regarding durability and safety. Injectable particulate human acellular dermal matrix (phADM) is a biologically derived extracellular matrix scaffold designed to support constructive dermis remodeling. This randomized, split-face, double-blinded clinical trial evaluated the efficacy of phADM as a facial skin booster in 20 adults with moderate cheek roughness. phADM was injected on one facial side, with hyaluronic acid serving as the contralateral control. Multiple skin parameters were assessed over 20 weeks using validated imaging and biophysical instruments. Mechanistic validation was conducted using complementary in vitro, ex vivo human skin, and in vivo rat models. Clinically, the phADM-treated side demonstrated greater improvements in skin density, volume, elasticity, wrinkle depth, pore area, hydration, and barrier-related parameters at multiple time points compared with HA. In ex vivo human skin, phADM showed homogeneous dermal distribution and preservation of extracellular matrix architecture, along with restoration of basement membrane-associated proteins following UVB irradiation. In vivo rat studies revealed fibroblast infiltration and localized neocollagenesis within the implanted matrix. In vitro assays further indicated enhanced fibroblast proliferation and extracellular matrix synthesis, increased hyaluronan production, suppression of pro-inflammatory cytokines in activated macrophages, and downregulation of melanogenesis-related genes in melanoma cells. No serious adverse events were observed during the clinical study. These findings indicate that phADM functions as a restorative skin booster that promotes durable dermis remodeling and functional rejuvenation with a favorable safety profile.