Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles (NCT03831477) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
United States15 participantsStarted 2018-12-12
Plain-language summary
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles.
. Able to read, understand and voluntarily provide written Informed Consent.
. Able and willing to comply with the treatment/follow-up schedule and requirements.
. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
Exclusion criteria
. Implantable defibrillators, cardiac pacemakers, and other metal implants
. Subjects with any implantable metal device in the treatment area
. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
. Current or history of any kind of cancer, or pre-malignant moles.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline