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 range25 Years – 65 Years
SexALL
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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.
✓. 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.
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.
✕. 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.