Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency De… (NCT05096247) | Clinical Trial Compass
CompletedNot Applicable
Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
United States48 participantsStarted 2021-09-03
Plain-language summary
The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.
Who can participate
Age range
18 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:
* A healthy male or female 18 years of age or older.
* Agrees to be treated with the TempSure device.
* 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 months, currently breast feeding or planning a pregnancy during the study.
* The subject has a cut, wound, or infected skin on the area to be treated.
* The subject is on local, oral, or systemic anesthetic agents.
* The subject has nerve insensitivity to heat in the treatment area.
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Exclusion Criteria for Icon Treatments Only:
* The subject is using systemic steroids (e.g. prednisone, dexamethasone) prior to or during the course of treatment.
* The subject has a medical condition or is receiving treatment that significantly compromise healing response.
* The subject has a history of light-induced seizures.
* The subject has a history of skin photosensitivity disorders.
* The…
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.