Study of Stem Cell-Derived Exosomes Combined With Laser or Microneedling to Treat Melasma and Improve Skin Penetration

What this Trial Is About

Researchers are evaluating the safety and effectiveness of human umbilical cord mesenchymal stem cell-derived exosomes hUCMSC-Exos as a new treatment approach for melasma, a challenging skin condition due to its complex causes and difficulty in treatment. This study aims to find ways to improve the penetration of these exosomes through the skin barrier to better treat melasma. The trial involves 80 patients with melasma divided into four groups receiving different treatments. Group A receives a 1565 nm non-ablative fractional laser combined with normal saline, while Groups B, C, and D receive treatments combining microneedles, the same laser, or a plasma device called Peninsula Blue Aurora Shumin Master PBASM with hUCMSC-Exos. Each participant undergoes four monthly treatment sessions, with treatment parameters adjusted based on individual skin characteristics. Participants will be monitored for pain after treatment, melasma severity using the MASI score, improvement rates, physician assessments, satisfaction, and any complications at six months post-treatment. The study includes regular evaluation of these outcomes to assess the potential benefits and safety of the treatment combinations over time.

Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration