Status:
COMPLETED
Study on the Safety, Efficacy of Home RF Cosmetic Instrument in the Treatment of Facial or Periorbital Wrinkles（F-MFR300-RD-003）
Lead Sponsor:
Flossom (GD) Beauty Technology Co., Ltd.
Conditions:
Skin Wrinkles
Eligibility:
All Genders
18+ years
Phase:
NA
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 exper...
Detailed Description
The purpose of the clinical trial was to see if home radiofrequency beauty devices were effective in treating adults for reducing skin wrinkles. It will also learn about the safety of home RF beauty d...
Eligibility Criteria
Inclusion
- (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).
Exclusion
- (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;
- (16) Receive semi-permanent fillers (poly-l-lactic acid, calci-hydroxyphospholite, etc.) within 24 months before treatment;
- (17) Have undergone facial medical or cosmetic surgery (e.g. eyelid/ eyebrow surgery, periorbital or perioral soft tissue enhancement, permanent fillers, permanent makeup, tattoos, etc.);
- (18) Use of drugs that may trigger photosensitization during the study period (such as quinolones, aspirin, hyd rochlorothiazide or furosemide);
- (19) Use of any medications that affect skin characteristics (e.g., vitamin A, steroids, thyroid medications, etc.) in the past 6 months;
- (20) Participate in a clinical trial of another drug or device in which the last treatment of the investigational drug/device occurred 3 months before the start of treatment in the study;
- (21) Plan to change previously used skin care products during the study period;
- (22) Other conditions deemed unsuitable for inclusion by the researcher.
Key Trial Info
Start Date :
March 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2023
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06565884
Start Date
March 28 2023
End Date
September 11 2023
Last Update
August 22 2024
Active Locations (1)
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1
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000