NCT05595525

Laser Treatment to Improve Skin Quality

A Prospective, Single-center, Double-blinded, Randomized, Split-face Study Evaluating 1064nm Versus 755nm Picosecond Lasers With Diffractive Lens Array for Improvement of Skin Quality

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To assess the efficacy of a 1064nm picosecond laser (PicoWay; Candela; Marlborough, MA) with diffractive lens array and a picosecond 755nm laser (PicoSure®; Cynosure®; Westford, MA) with diffractive lens array in subjects for the improvement of facial skin quality. Secondary objectives of this clinical trial are to assess whether the 1064nm or 755nm picosecond laser is more efficacious in improving facial skin quality, safety of the procedure, comfortability of the procedure, and subject satisfaction.

Detailed description

subject will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half. For additional comfort, cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5 will be used throughout the treatment. After each treatment, subjects will be provided with CeraVe gentle facial cleanser (CeraVe; New York, NY) and CeraVe lotion (CeraVe; New York, NY) to be used twice daily for two weeks. Additionally, a mineral CeraVe sunscreen (CeraVe; New York, NY) will also be provided to subjects to be used every morning with reapplication every two (2) hours if going outside for the entirety of the study.

Conditions

• Skin Quality

Interventions

Type	Name	Description
DEVICE	1064NM pico Laser	There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality.
DEVICE	755NM pico Laser	There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-10-27
• Last updated: 2022-10-27

Regulatory

• FDA-regulated device study