Study on the Safety, Efficacy of Home RF Cosmetic Instrument in the Treatment of Facial or Periorbital Wrinkles（F-MFR300-RD-003）

NCT06565884 | Completed

• 1 other identifier: F-MFR300-RD-003
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter trial with randomized control and evaluator blind method, which meets the screening criteria total of 224 subjects were enrolled and randomly divided into control group and experiment according to 1:1 ratio Group), the subjects in the control group used medical ultrasonic coupler, and the subjects in the test group used test instruments Combined with medical ultrasonic coupler, use 5 days per week according to the prescribed use method (duration:Use the whole face for 10 minutes, use twice a day, a total of 20 minutes), continuous use 12Week. The changes of relevant clinical indicators and laboratory instrument measurements were evaluated. Objective : To evaluate the efficacy of radiofRF in reducing skin wrinkles and treating loose skin after 12 weeks of use of the test product Effectiveness and safety of relaxation and firming of skin tissue. The subjects were adults aged 18 years and above, regardless of gender, and had obvious wrinkles on the skin around the face and eyes (according to the selection Standard confirmation).

Conditions

Skin Wrinkles

Keywords

Rf beauty device for home use; Treatment of facial or periorbital wrinkles

Outcome Measures

Primary Outcomes (1)

• Wrinkle reduction efficiency based on Fitzpatrick score

  After 12 weeks of treatment, wrinkles were more severe on a 0-9 scale (Fitzpatrick scale) Percentage of subjects with at least one grade (1 point) reduction at baseline.

  12th week

Secondary Outcomes (9)

• Wrinkle reduction efficiency based on Fitzpatrick score

  6th week

• R2 values measured by the Cutometer dual MPA580

  6th week\12th week

• F4 values measured by the Cutometer dual MPA580

  6th week\12th week

• PRIMOS-CR measures the length of skin wrinkles

  6th week\12th week

• PRIMOS-CR measures the length and number of skin wrinkles

  6th week\12th week

Study Arms (2)

Home radiofrequency skin treatment instrument

EXPERIMENTAL

Radiofrequency skin therapy instrument with medical ultrasound coupler is used for 20 minutes a day, 5 days a week

Device: Home radiofrequency skin treatment instrument

Medical ultrasound coupler

PLACEBO COMPARATOR

Medical ultrasound coupler is applied to the face for 20 minutes a day, 5 days a week

Other: Ultrasonic coupler for medical purposes

Interventions

Home radiofrequency skin treatment instrument DEVICE

Subjects in the experimental group were treated with the test instrument combined with medical ultrasonic coupler for 5 days a week according to the prescribed use method (duration of use: 10 minutes for the whole face, continuous use twice a day, a total of 20 minutes) for 12 weeks. To evaluate the reduction of wrinkles before and after treatment and the changes of laboratory instruments.

Home radiofrequency skin treatment instrument

Ultrasonic coupler for medical purposes OTHER

In control group, medical ultrasonic coupler was evenly applied on face and orbit for 5 days a week (duration: 20 minutes) for 12 consecutive days Week. To evaluate the reduction of wrinkles and the change of laboratory instruments before and after use.

Medical ultrasound coupler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Adults aged 18 and above, male or female;
• (2) Fitzpatrick's wrinkles and elasticity scores around the face and eyes were 2-7 points (on-site assessment);
• (3) To avoid sun exposure during the test;
• (4) Be able to read Chinese and accurately understand, and sign the informed consent of the test;
• (5) can cooperate with and participate in the test return visit time, and timely reflect their own health status or any changes in drugs, adverse reaction symptoms;
• (6) Urine pregnancy reaction is negative (women of childbearing age).

You may not qualify if:

• (1) Abnormal vital signs (blood pressure, pulse, body temperature), except for minor abnormalities that are not clinically significant as determined by the doctor;
• (2) There is a pacemaker or internal defibrillator in the body, or any other active electrical implant anywhere in the body;
• (3) The treatment area has permanent implants, such as metal plates and screws (e.g. dentures, metal teeth), silicone implants or injected chemicals;
• (4) There is or has been a history of skin cancer, or any other type of cancer, or malignant pre-nevus;
• (5) serious comorbidities, such as heart disease, epilepsy, high blood pressure and liver or kidney disease;
• (6) Plan to become pregnant or breastfeed during the study period, or less than 6 months after delivery;
• (7) Have a history of bleeding and clotting, or long-term use of anticoagulation and antiplatelet drugs (aspirin ≤81mg daily is not excluded);
• (8) Suffering from autoimmune diseases;
• (9) have an immunosuppressive disease such as AIDS, or an impaired immune system caused by the use of immunosuppressive drugs (investigators' judgment);
• (10) Subjects with a history of heat-stimulated disease, such as recurrent herpes simplex in the treatment area, should only be treated after a preprevention regimen;
• (11) Poor control of diseases related to the endocrine system as determined by the investigator, such as diabetes or thyroid dysfunction;
• (12) Any active condition in the treatment area identified by the investigator, such as ulcers, eczema, or other skin lesions;
• (13) A history of skin diseases, such as keloid, abnormal wound healing, psoriasis, etc.;
• (14) Any invasive or non-invasive treatment (such as hair removal, light rejuvenation, microneedles or chemical exfoliation, etc.) in the treated area within 3 months prior to treatment;
• (15) Received RF microneedle therapy, injection of fillers or botulinum toxin within 6 months prior to treatment;

Sponsors & Collaborators

• Flossom (GD) Beauty Technology Co., Ltd.: lead

Study Sites (1)

Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Study Officials

• Wei Lai, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Three doctors set up a blind evaluation group to evaluate the photos of the subjects before and after receiving the device treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The method of randomized control and evaluator blindness is suitable for screening A total of 224 subjects were enrolled and randomly divided into control group and experiment according to 1:1 ratio Group)

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: March 28, 2023
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)