Efficacy and safety of a novel 532-nm picosecond Nd:YAG laser for the treatment of freckles in Chinese patients: a randomized, split-face, multicenter, noninferiority trial.

Abstract

Background: The picosecond Nd:YAG laser is a standard treatment for freckles. However, factors such as cost and technology barriers may limit accessibility, necessitating evaluation of alternative systems.

Objectives: To evaluate the noninferiority and safety of a novel 532-nm picosecond Nd:YAG laser versus an established system for treating freckles.

Methods: In this randomized, evaluator-blinded, split-face trial, 84 participants received a single treatment session. Contralateral facial sides were randomly assigned to the investigational or control device in a 1:1 ratio. The primary endpoint was the response rate at week 8. Secondary endpoints included the cure rate, investigator-assessed improvement, patient satisfaction and procedural tolerability. Safety was assessed by adverse events monitoring.

Results: The investigational device demonstrated noninferiority to the control (response rates: 97.6% vs. 97.6%; difference, 0.0%; 95% confidence interval: -3.30% to 3.30%) with comparable cure rates (13.1% vs. 9.5%, p = .527). Participant satisfaction was significantly higher with the investigational device (72.6% vs. 58.3%, p = .001). Treatment duration suggested an association with superior efficacy (OR = 2.07, 95% CI: 1.14-3.76, p = .016). No serious adverse effects occurred.

Conclusion: The novel 532-nm picosecond Nd:YAG laser is noninferior to the established system, with comparable short-term efficacy and safety. Further studies are needed to assess long-term safety.