NCT07352631

A Novel 532-nm Picosecond Laser for Freckle Treatment in Chinese Patients

Efficacy and Safety of a Novel 532-nm Picosecond Nd:YAG Laser for the Treatment of Freckles in Chinese Patients: A Prospective, Randomized, Split-Face Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial was to learn if a novel laser device works as well and is as safe as an already approved laser device for removing freckles on the face. The main questions it aimed to answer were: After 8 weeks, did the novel laser make freckles fade by 60% or more for a similar number of participants as the approved laser? What side effects did participants have from either laser? Researchers compared the results from two sides of each participant's face to see if the novel laser worked as well as the approved laser. One side of the face was treated with the novel laser, and the other side was treated with the approved laser. A computer randomly chose which side received which laser. Participants in this study: Were adults (aged 18-65) with similar freckles on both sides of their face. Received one laser treatment session, using the two different lasers on opposite sides of their face. Returned to the clinic for check-up visits about 4 weeks and 8 weeks after the treatment. Had photos taken of their face at each visit so doctors could compare the fading of their freckles. Answered questions about any pain during the treatment and their satisfaction with the results.

Conditions

• Freckles

Interventions

Type	Name	Description
DEVICE	Nd:YAG Picosecond Laser Therapy Device	This is an investigational medical device. It is a Nd:YAG laser system that generates picosecond-duration pulses of light at a wavelength of 532 nanometers (nm). It is designed for the treatment of benign epidermal pigmented lesions, including freckles, through selective photothermolysis and photomechanical effects.
DEVICE	Nd:YAG Picosecond Laser Therapy System	This is a marketed (approved) medical device used as an active comparator. It is a Nd:YAG laser system that generates picosecond-duration pulses of light at a wavelength of 532 nanometers (nm). It is indicated for the treatment of benign epidermal pigmented lesions, including freckles.

Timeline

• Start date: 2024-12-11
• Primary completion: 2025-06-12
• Completion: 2025-08-27
• First posted: 2026-01-20
• Last updated: 2026-01-21

Locations

2 sites across 1 country: China