NCT05987319

Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions

Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of the Potenza device 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 12 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups. Group A will receive treatments on the face, neck, and/or body. Group B will receive split-face treatments where each side of the face may be treated with different tips. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments.

Conditions

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

Interventions

Type	Name	Description
DEVICE	RadioFrequency Microneedling Device	RadioFrequency device will be used for the treatment of dermatologic conditions.

Timeline

• Start date: 2023-07-24
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-08-14
• Last updated: 2024-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study