Efficacy and Safety of Non-cross-Linked Hyaluronic Acid Injections for Facial Skin Biorevitalization: A Single-Center, Open-Label, Single-Arm, Uncontrolled, Post-marketing Study

Abstract

BACKGROUND: Biorevitalization is a minimally invasive cosmetic procedure that involves the targeted intradermal injection of bioactive substances designed to enrich the skin and stimulate its natural regenerative capabilities. The aim of this single-center, open-label, single-arm, uncontrolled, post-marketing study was to examine the effectiveness and safety of biostimulatory injections using a proprietary, sterile gel containing non-cross-linked hyaluronic acid (Foliage Hydrofil R) for facial skin rejuvenation. METHODS: The trial was registered with ClinicalTrials.gov (NCT07010549). The intended target population comprised adults with mild-to-moderate facial photoaging and Fitzpatrick skin types III-IV, without active inflammatory dermatoses or recent aesthetic interventions. Twenty-four Caucasian subjects (21 women, three men; mean age: 44 +/- 7.1 years) received three intradermal injections of the study product at three-week intervals. The primary endpoint was the change from baseline in skin capacitance, an objective measure of hydration, assessed via corneometry. Secondary endpoints included investigator and subject assessments of aesthetic improvement, while safety was evaluated through continuous adverse event monitoring. RESULTS: The mean skin capacitance was 23.1 arbitrary units (a.u.) at baseline and increased to 33.2 a.u. at the end of the study, indicating a significant improvement in skin hydration (p : The mean skin capacitance was 23.1 arbitrary units (a.u.) at baseline and increased to 33.2 a.u. at the end of the study, indicating a significant improvement in skin hydration (p CONCLUSIONS: This study demonstrated that the tested non-cross-linked hyaluronic acid gel safely improves skin hydration and patient satisfaction in facial biorevitalization. Although promising, these findings are constrained by the study's uncontrolled, small-scale design; therefore, larger randomized controlled trials are required to confirm these outcomes and evaluate their long-term durability. Copyright © 2025, Chahine et al.