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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 65
Healthy Volunteers: f
View:
• A healthy, non-smoking male or female between the age of 22-65 years old.
• Fitzpatrick skin type I to VI.
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document.
Locations
United States
Massachusetts
Cynosure, Inc.
RECRUITING
Westford
Contact Information
Primary
Jamie Trimper
jamie.trimper@cynosure.com
9782564200
Time Frame
Start Date: 2023-07-24
Estimated Completion Date: 2024-08
Participants
Target number of participants: 20
Treatments
Experimental: General Treatment
Subjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins.
Experimental: Split-face treatment
Subjects will receive split-face treatments where each side of the face may be treated with different tips.
Related Therapeutic Areas
Sponsors
Leads: Cynosure, Inc.