Efficacia e sicurezza del filler in collagene per iniezione intradermica: uno studio controllato prospettico multicentrico randomizzato.

BACKGROUND: With the increasing demand for minimally invasive aesthetic procedures, intradermal injection has emerged as a promising method to improve skin condition. However, there is a lack of robust clinical evidence supporting the efficacy and safety of intradermal collagen injections. OBJECTIVE: The purpose of this study is to investigate the improvement of facial skin and safety of collagen intradermal injections. METHODS: This prospective, multicenter, randomized, assessor-masked clinical trial enrolled 480 subjects aged 18-65 seeking facial skin enhancement. Subjects were randomized into treatment (n = 240) and control (n = 240) groups. The treatment group received three sessions of intradermal collagen injections at four-week intervals. Assessments included the Global Aesthetic Improvement Scale (GAIS), composite scale for skin dryness and dull complexion, Allergan Fine Lines Scale (AFLS), Allergan Skin Roughness Scale (ASRS), skin hydration, elasticity, and safety evaluations. RESULTS: The GAIS and skin improvement rates showed significant differences between groups (P < 0.0001), with the treatment group demonstrating superior efficacy. No significant differences were observed in skin hydration and elasticity (P > 0.05). The treatment group exhibited higher improvement rates in GAIS, dull complexion, fine lines, and skin roughness at 4 weeks post-final injection compared to the control group. No severe treatment-emergent adverse events related to the trial device occurred. CONCLUSION: Intradermal collagen injections significantly enhance skin texture and demonstrate safety and reliability in clinical settings, offering a favorable risk-benefit ratio for appropriate candidates. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .