NCT05811026

Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

An Open-Label, Single Center Clinical Study to Evaluate the Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research project is to investigate the treatment design, therapeutic effects and safety of the 1927 nm laser for the rejuvenation of the skin around the eyes.

Detailed description

The chromophore of the 1927 nm diode laser is mainly water, which can be used for skin rejuvenation. This study intends to use the Solta CLEAR+BRILLIANT Laser System, featuring a 1927 nm diode laser with 5 mJ energy, a treatment spot of 140 μm, a treatment depth of 170 μm, and a treatment coverage of approximately 5% per energy level after four rounds of treatment using the patented Intelligent Optical Tracking® System (IOTs). The purpose of this research project is to investigate the treatment design, therapeutic effects and safety of the 1927 nm laser for the rejuvenation of the skin around the eyes. This is an open-label, single-center clinical trial. Participants will be randomized into treatment groups, including Group A (treatment interval of 2 weeks) or Group B (treatment interval of 4 weeks).

Conditions

• Laser
• Periorbital

Interventions

Type	Name	Description
DEVICE	Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval)	* Visit 1 (W0): Clear + Brilliant™ Permea device periorbital treatment * Visit 2 (W2): Clear + Brilliant™ Permea device periorbital treatment * Visit 3 (W4): Clear + Brilliant™ Permea device periorbital treatment * Visit 4 (W8): Four weeks after the third treatment, a follow-up assessment will be performed
DEVICE	Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)	* Visit 1 (W0): Clear + Brilliant™ Permea device periorbital treatment * Visit 2 (W4): Clear + Brilliant™ Permea device periorbital treatment * Visit 3 (W8): Clear + Brilliant™ Permea device periorbital treatment * Visit 4 (W12): Four weeks after the third treatment, a follow-up assessment will be performed

Timeline

• Start date: 2023-03-15
• Primary completion: 2023-06-21
• Completion: 2024-12-31
• First posted: 2023-04-13
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study