A Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With Sk… (NCT06228833) | Clinical Trial Compass
UnknownNot Applicable
A Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With SkinCeuticals A.G.E and Skinceuticals CE FERULIC for Improving Facial Skin Elasticity, Tightening and Fading Fine Lines
50 participantsStarted 2024-01-30
Plain-language summary
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines
Who can participate
Age range
25 Years – 65 Years
Sex
FEMALE
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 women, skin quality is not limited, aged 25 \~ 65 years old face old \~ moderate aging group;
. subjects facial skin rough, loose, lack of elasticity;
. Subjects with multiple facial fine lines, decree lines or puppet lines areas have static fine lines trend, the lower part showed signs of loosening;
. Subjects with consistent facial skin status on both sides and planning to receive monopolar radiofrequency treatment;
. Be able to cooperate well with the tester and maintain the regularity of life during the study;
. Be able to read and understand all contents of the informed consent form, and voluntarily sign the informed consent form (ICF);
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.
. Agreed not to use any cosmetics, drugs and health products that have an impact on the results during the trial;
Exclusion criteria
. Subjects with contraindications to monopolar radiofrequency treatment (such as malignant tumors, acute systemic infection, metal implants or active implants in the body such as cardiac pacemakers/defibrillators, etc.) or contraindications to A.G.E./CE use (or allergies to other skin care components);
. Subjects with facial skin diseases, infections, inflammation, etc. that may affect the judgment of the test results;
. Subjects with hypertrophic scar or scar constitution;
. Subjects who have experienced tightening medical treatment (Gemma, Fotona 4D, ultrasonic cannon, ultrasonic scalpel, gold microneedle, etc.) in the past 3 months;
. Subjects who have oral and topical cosmetic products that may affect the study results within 2 weeks;
. Subjects who participate in drug clinical trials or other trials within 30 days, or subjects who have systemic use of drugs that may affect the study results within the past 1 week;
. Pregnant or lactating women, or recent plans to prepare for pregnancy;
. Other subjects who are not suitable for participating in this study as assessed by the investigator.