Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction … (NCT05097573) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks
Switzerland17 participantsStarted 2019-05-09
Plain-language summary
This is a prospective, single centre, evaluator-blind study of the performance of fractional radiofrequency (RF) for the treatment and revision of stretch marks. The study will evaluate the progress of 15 subjects requesting treatment of stretch marks. The study will involve four treatments on both sides of the face with 4 week intervals between each treatment. Subjects will be followed at 12 and 16 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.
Who can participate
Age range
18 Years – 60 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, 18-60 years of age who are seeking treatment for their stretch marks
. Fitzpatrick skin type I-IV
. Able to read, understand and voluntarily provide written Informed Consent.
. Able and willing to comply with the treatment/follow-up schedule and requirements.
Exclusion criteria
. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
. Subjects with any implantable metal device in the treatment area
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
Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment
. Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
. Current or history of any kind of cancer, or dysplastic nevi in the treated area.
. Severe concurrent conditions, such as cardiac disorders.
. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
. Poorly controlled endocrine disorders, such as diabetes.