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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.
This is a single-arm prospective study aimed at evaluating the safety and efficacy of nebulyft device treatment of facial areas. Nebulyft device is a low-power, radio frequency device designed to reduce facial wrinkles. 42 subjects will be enrolled in a single clinical site.
The included subjects will use the device at specified areas, including the cheek (for nasolabial fold lines), and outer eye corners (for crow's feet lines). Each side of the nasolabial fold receives 4 minutes of treatment, and each outer eye corner receives 4 minutes of treatment too. The total time for each treatment is 16 minutes. The study consists of at least five wrinkle reduction treatments a week at home for four consecutive weeks. The first treatment session will be conducted under the supervision of the principal investigator (PI), and the remaining sessions will be conducted at home, with remote assistance from the PI when necessary.
A Self-selection and Labeling Comprehension study will be conducted that includes three main questions regarding the intended use of the device, treatment areas, and the possibility of using the device according to the contraindications.
A usability study will be conducted as part of the clinical study. The study was divided into several steps. The PI must observe the test subject to ensure compliance with all the procedures.
In the first visit, the independent treatment for wrinkle reduction was performed under the investigator's observation. Patients were asked to rate the pain level and note any problems/difficulties during the treatments.
The subjects perform treatment at home for 4 continuous weeks and return for photography at the end of the treatment. They will be asked to rate the pain level of the treatment during the visit.
The subjects take final photographs 4 weeks after finishing the treatment and rate the overall satisfaction of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | receive treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nebulyft | Device | Micro Radiofrequency Skin Treatment Device(nebulyft) |
|
| Measure | Description | Time Frame |
|---|---|---|
| wrinkle improvement at least one score point of Fitzpatrick wrinkle scale | Three independent board-certified dermatologists assess patient photographs taken at baseline (before treatment initiation) and compare them to those captured one month after completing the home-based treatment using the Fitzpatrick wrinkle scale, which ranges from 1 (least wrinkles) to 9 (most wrinkles). A treatment is considered successful if at least two of the three evaluators observe reduction of at least one score-point in any of the treated areas; otherwise, it is deemed a failure. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| subjective wrinkle improvement in wrinkle appearance as measured by satisfactory questionnaires | Subjective wrinkle improvement is assessed based on participants responses to satisfaction questionnaires. There are four questions in total, each rated on a scale of 1 to 4, where 1 indicates very dissatisfied; and 4 indicates very satisfied. The scores from all four questions are summed up, and the total score is used to determine the participants' overall satisfaction with the treatment results. |
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Inclusion Criteria:
All subjects received oral and electronic consent in accordance with local laws and regulations. Informed consent explains the nature and purpose of the study and the potential risks involved in the study, and emphasizes the voluntary nature of the test, and the subjects can exit the study at any time for any reason. All subjects can ask questions about the research and give sufficient time before signing. All informed consent must be signed before the start of the study.
Exclusion Criteria:
doesn't limit
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| Name | Affiliation | Role |
|---|---|---|
| Tony Shum, MD | DSC Laser & Skin Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DSC Laser Skin Care Center | San Gabriel | California | 91776 | United States |
the data will be published on paper
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This clinical design adopted the single-group target value method
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| From enrollment to the end of treatment at 8 weeks |