NCT06623214

Assessment of the Safety and Effectiveness of a Micro-RF Skin Treatment Device (nebulyft）

Assessment of the Safety and Effectiveness of a Micro Radiofrequency Skin Treatment Device (nebulyft)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Hangzhou Rebecca Medical Science and Technology Ltd. · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Wrinkle Reduction

Interventions

Type	Name	Description
DEVICE	nebulyft	Micro Radiofrequency Skin Treatment Device(nebulyft)

Timeline

• Start date: 2024-06-07
• Primary completion: 2024-08-13
• Completion: 2024-08-13
• First posted: 2024-10-02
• Last updated: 2024-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study