Assessment of the Safety and Effectiveness of a Micro-RF Skin Treatment Device (nebulyft） (NCT06623214) | Clinical Trial Compass
CompletedNot Applicable
Assessment of the Safety and Effectiveness of a Micro-RF Skin Treatment Device (nebulyft）
United States42 participantsStarted 2024-06-07
Plain-language summary
The objective of the study is to evaluate the safety, efficacy and usage compliance of the home-use device nebulyft for self-treatment of wrinkles appearance. The participants do treatment 5 time /week and last 4 weeks. Each treatment takes 16min to complete. Photographs will be taken before treatment and 1 month after the completion of treatment to compare the wrinkle scale.
Who can participate
Age range
25 Years – 65 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
. Adult subjects aged 25-65.
. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, including the permission to use photography.
. The subjects should be willing to comply with the study procedure and schedule, including the follow-up visits, and will refrain from using any other or similar treatment technologies (i.e., Laser, RF, IR) for the facial condition.
. The subjects will carry on with their usual diet and exercise and will not have a significant weight change during the study.
. The subjects are able to read the User Manual in English.
. The subjects should have II-IV Fitzpatrick wrinkle skin type.
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
wrinkle improvement at least one score point of Fitzpatrick wrinkle scale
Timeframe: From enrollment to the end of treatment at 8 weeks
Trial details
NCT IDNCT06623214
SponsorHangzhou Rebecca Medical Science and Technology Ltd.
. The subjects should have visible facial wrinkles.
Exclusion criteria
. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
. Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.
. Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles per investigator\'s discretion.
. Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases per investigator\'s discretion.
. Pregnancy or nursing, as well as 3-6 months post-childbirth.
. History of bleeding coagulopathies, or prolonged use of anticoagulants (daily aspirin dosing of 81 mg is acceptable).
. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medication per investigator\'s discretion.
. Subjects with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.