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

NCT06623214 | Completed FDA Device

• 1 other identifier: RBTBAP202404 V1.0
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkle Reduction

Keywords

wrinkle reduction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• subjective wrinkle improvement in wrinkle appearance as measured by satisfactory questionnaires

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

treatment

EXPERIMENTAL

receive treatment

Device: nebulyft

Interventions

nebulyft DEVICE

Micro Radiofrequency Skin Treatment Device(nebulyft)

treatment

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: doesn\'t limit
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Poorly controlled endocrine disorders, such as diabetes or thyroid abnormality per investigator\'s discretion.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash per investigator\'s discretion.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin per investigator\'s discretion.
• Any surgery in treatment area within 3 months prior to treatment or before complete healing.
• Injected fillers in the treatment area in the last 6 months and Botox in the treatment area in the last 3 month.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• As per the practitioner\'s discretion, refrain from treating any condition that might make it unsafe for the subject.

Sponsors & Collaborators

• Hangzhou Rebecca Medical Science and Technology Ltd.: lead

Study Sites (1)

DSC Laser Skin Care Center

San Gabriel, California, 91776, United States

Location

Study Officials

• Tony Shum, MD

  DSC Laser & Skin Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This clinical design adopted the single-group target value method

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: June 7, 2024
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-09

Locations

US (1)