Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions.
Cynosure, Inc.
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.
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.
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3…
Interventions
- DeviceRadioFrequency Microneedling Device
RadioFrequency device will be used for the treatment of dermatologic conditions.
Location
- Cynosure, Inc.Westford, Massachusetts