NCT05097157

Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Conditions

• Wrinkle
• Fine Lines
• Crepey Skin
• Acne Scars
• Acne
• Enlarged Pores
• Stretch Marks
• Loose Skin

Interventions

Type	Name	Description
DEVICE	Potenza	Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.

Timeline

• Start date: 2019-09-03
• Primary completion: 2021-04-12
• Completion: 2021-06-21
• First posted: 2021-10-28
• Last updated: 2022-06-09
• Results posted: 2022-06-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study