NCT03285581

Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction

Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Cutera Inc. · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this pivotal investigation is to evaluate the safety and efficacy of the Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.

Detailed description

This is an Open-label, Prospective, Multicenter Pivotal Study of approximately 40 male or female subjects, age 25 to 65 years who desire RF treatment for wrinkle reduction and improvement in skin quality. Subjects will receive RF treatments with the Cutera truSculpt™ radiofrequency (RF) device. Subjects will return to the site after study treatments have been delivered 12 weeks post-final treatment.

Conditions

• Wrinkle Reduction

Interventions

Type	Name	Description
DEVICE	truSculpt RF	Subjects will receive RF treatments

Timeline

• Start date: 2017-08-15
• Primary completion: 2018-12-20
• Completion: 2018-12-20
• First posted: 2017-09-18
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study