Safety and Efficacy of Mesotherapy with Placenta Polypeptide Injection for Moderate-to-Severe Sensitive Skin: A Multicenter, Randomized, Controlled Trial

Background: Sensitive skin (SS) is a prevalent condition characterized by cutaneous hyperreactivity and neurosensory inflammation, for which effective treatments remain limited. Placenta polypeptide injection (PPI), rich in anti-inflammatory cytokines and growth factors, presents a promising therapeutic candidate. This study aimed to rigorously evaluate the safety and efficacy of mesotherapy with PPI for treating moderate-to-severe SS. Methods: In this multicenter, open-label, randomized controlled trial, 156 adults with moderate-to-severe SS were randomized (PPI group: control group = 2:1) to receive three sessions of mesotherapy with PPI (4 mL per session at 30-day intervals) or no treatment (control group) over a 90-day period. The primary endpoint was the change in total facial skin hemoglobin content, a proxy measure of cutaneous inflammation, from baseline to Day 90, quantified by a 3D skin analysis system. Safety was monitored through adverse events (AEs) and laboratory assessments. Results: A total of 154 patients were included in the full analysis set (FAS; 103 PPI group, 51 control group). At Day 90, the PPI group demonstrated a significantly greater reduction in skin hemoglobin content compared to the control group (mean change, − 1705.82 ± 1808.17 vs − 756.65 ± 1493.17; P=0.001). Furthermore, a significantly higher proportion of patients in the PPI group reported aesthetic improvement on the GAIS (88.9% vs 5.9% rated as “improved” to “very much improved”; P < 0.001). The incidence of AEs was comparable between the PPI (5.8%) and control (9.6%) groups (P = 0.376), with no serious AEs reported. Conclusion: Mesotherapy with placenta polypeptide injection is an effective and safe treatment for moderate-to-severe sensitive skin, leading to significant reductions in cutaneous inflammation metrics and high rates of patient-reported aesthetic improvement. Trial Registration: This study was prospectively registered at Chinese Clinical Trial Registry (No. ChiCTR2400080988, Date: 20/02/2024). Keywords: sensitive skin, placenta polypeptide injection, mesotherapy, inflammation, randomized controlled trial, hemoglobin content