Study on the Safety, Efficacy of Home RF Cosmetic Instrument in the Treatment of Facial or Periorbital Wrinkles(F-MFR300-RD-003)
- Conditions
- Skin Wrinkles
- Registration Number
- NCT06565884
- Lead Sponsor
- Flossom (GD) Beauty Technology Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 224
Inclusion Criteria:<br><br> - (1) Adults aged 18 and above, male or female;<br><br> - (2) Fitzpatrick's wrinkles and elasticity scores around the face and eyes were 2-7<br> points (on-site assessment);<br><br> - (3) To avoid sun exposure during the test;<br><br> - (4) Be able to read Chinese and accurately understand, and sign the informed consent<br> of the test;<br><br> - (5) can cooperate with and participate in the test return visit time, and timely<br> reflect their own health status or any changes in drugs, adverse reaction symptoms;<br><br> - (6) Urine pregnancy reaction is negative (women of childbearing age).<br><br>Exclusion Criteria:<br><br> - (1) Abnormal vital signs (blood pressure, pulse, body temperature), except for minor<br> abnormalities that are not clinically significant as determined by the doctor;<br><br> - (2) There is a pacemaker or internal defibrillator in the body, or any other active<br> electrical implant anywhere in the body;<br><br> - (3) The treatment area has permanent implants, such as metal plates and screws (e.g.<br> dentures, metal teeth), silicone implants or injected chemicals;<br><br> - (4) There is or has been a history of skin cancer, or any other type of cancer, or<br> malignant pre-nevus;<br><br> - (5) serious comorbidities, such as heart disease, epilepsy, high blood pressure and<br> liver or kidney disease;<br><br> - (6) Plan to become pregnant or breastfeed during the study period, or less than 6<br> months after delivery;<br><br> - (7) Have a history of bleeding and clotting, or long-term use of anticoagulation and<br> antiplatelet drugs (aspirin =81mg daily is not excluded);<br><br> - (8) Suffering from autoimmune diseases;<br><br> - (9) have an immunosuppressive disease such as AIDS, or an impaired immune system<br> caused by the use of immunosuppressive drugs (investigators' judgment);<br><br> - (10) Subjects with a history of heat-stimulated disease, such as recurrent herpes<br> simplex in the treatment area, should only be treated after a preprevention regimen;<br><br> - (11) Poor control of diseases related to the endocrine system as determined by the<br> investigator, such as diabetes or thyroid dysfunction;<br><br> - (12) Any active condition in the treatment area identified by the investigator, such<br> as ulcers, eczema, or other skin lesions;<br><br> - (13) A history of skin diseases, such as keloid, abnormal wound healing, psoriasis,<br> etc.;<br><br> - (14) Any invasive or non-invasive treatment (such as hair removal, light<br> rejuvenation, microneedles or chemical exfoliation, etc.) in the treated area within<br> 3 months prior to treatment;<br><br> - (15) Received RF microneedle therapy, injection of fillers or botulinum toxin within<br> 6 months prior to treatment;<br><br> - (16) Receive semi-permanent fillers (poly-l-lactic acid, calci-hydroxyphospholite,<br> etc.) within 24 months before treatment;<br><br> - (17) Have undergone facial medical or cosmetic surgery (e.g. eyelid/ eyebrow<br> surgery, periorbital or perioral soft tissue enhancement, permanent fillers,<br> permanent makeup, tattoos, etc.);<br><br> - (18) Use of drugs that may trigger photosensitization during the study period (such<br> as quinolones, aspirin, hyd rochlorothiazide or furosemide);<br><br> - (19) Use of any medications that affect skin characteristics (e.g., vitamin A,<br> steroids, thyroid medications, etc.) in the past 6 months;<br><br> - (20) Participate in a clinical trial of another drug or device in which the last<br> treatment of the investigational drug/device occurred 3 months before the start of<br> treatment in the study;<br><br> - (21) Plan to change previously used skin care products during the study period;<br><br> - (22) Other conditions deemed unsuitable for inclusion by the researcher.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wrinkle reduction efficiency based on Fitzpatrick score
- Secondary Outcome Measures
Name Time Method Wrinkle reduction efficiency based on Fitzpatrick score;R2 values measured by the Cutometer dual MPA580;F4 values measured by the Cutometer dual MPA580;PRIMOS-CR measures the length of skin wrinkles;PRIMOS-CR measures the length and number of skin wrinkles;PRIMOS-CR measures the length and number of skin wrinkles;PRIMOS-CR measures the length and number of skin wrinkles;Lower face sag evaluation;Subject satisfaction evaluation