NCT06231914

Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. The main questions it aims to answer are: * Efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and skin elasticity * The changes in texture and pore volume using Antera * The changes in bioengineering assessment: melanin index, erythema index, sebum level * Adverse events Participants will be treated with 3 sessions of fractional 1064-nm picosecond laser (full face 4 passes, vector lines 4 passes), spaced 4 weeks apart. Follow-up visits 1, 3, and 6 months after the last treatments.

Detailed description

The efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, BMI \< 25 kg/m2, and have mild to moderate facial laxity.

Conditions

• Laxity; Skin

Interventions

Type	Name	Description
DEVICE	StarWalker® PQX	Third-generation ASP-powered technology for ultra performance: Highest pico power \& energy, shortest pico pulse width, wide range of laser wavelengths, exceptional spot size capabilities, largest fluence spectrum for flat-top handpieces

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-10-01
• Completion: 2025-03-01
• First posted: 2024-01-30
• Last updated: 2024-01-30

Locations

1 site across 1 country: Thailand

Regulatory

• FDA-regulated device study