NCT06023303

Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of the Radiofrequency microneedling devices (Potenza and Morpheus) used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Detailed description

Up to 20 subjects will be enrolled at 1 study center. Subjects will be enrolled into one of 2 groups. Group A will receive split face treatments with the Potenza and Morpheus. Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects will receive up to 3 treatments with Potenza (and Morpheus).

Conditions

• Dermatologic Conditions

Interventions

Type	Name	Description
DEVICE	Potenza	The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.
DEVICE	Morpheus	The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.

Timeline

• Start date: 2023-06-21
• Primary completion: 2023-08-10
• Completion: 2023-08-10
• First posted: 2023-09-05
• Last updated: 2024-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study