NCT05388604

Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging

Prospective Clinical Study To Evaluate The Efficacy And Safety Of Paired Treatment With A Picosecond 755nm Alexandrite Laser With Focused Lens Array And Radiofrequency Microneedling For Facial Aging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The intended use of the radiofrequency and microneedling devices used in this study is to assess the efficacy and safety of paired treatment for the treatment of facial aging.

Detailed description

Subjects are to be enrolled in this clinical study if they are a healthy male or female 40 - 65 years of age. Up to 35 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face.

Conditions

• Wrinkle
• Photoaging
• Dyschromia

Interventions

Type	Name	Description
DEVICE	RF device	The entire defined treatment area will then be treated by delivering adjacent pulses with minimal overlap of 10% or less. Parameters may be adjusted throughout the treatment in order to increase subject comfort.
DEVICE	Microneedling device	Test spots may be performed prior to the first treatment. Test spots may be performed prior to the first treatment. It will follow a similar procedure to treatment but only in an inconspicuous place, such as behind the ear, in an area no larger than 2in x 2in. The tip will be placed in contact with the skin, and parameters may be adjusted throughout the treatment and will determined by the Clinician.

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2022-05-24
• Last updated: 2023-10-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study