An interventional study of Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinkles and The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinkles in Improve Facial Wrinkles, sponsored by Peking University Third Hospital. Completed at 1 site in China. Open to participants aged 23 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Prevention
Evaluate the clinical efficacy and safety of the radiofrequency skin therapy device (model specification: RFM-01) produced by ReFumei (Hunan) Technology Co., Ltd. for improving facial skin wrinkles
Peking University Third Hospital is the lead sponsor of 749 studies on the registry; 270 are open to participants now.
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① Healthy adults aged 20 to 60, regardless of gender;
Exclusion Criteria:
① Merge severe cardiovascular and cerebrovascular diseases or other systemic diseases.
Combined with systemic diseases or local skin diseases that may affect wound healing, such as diabetes with poor blood sugar control, immune system diseases, scar constitution, local skin inflammation, skin cancer, etc.
The treatment area combines the following situations:
1) Suffering from any skin disease (such as acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, herpes zoster, infection or scarring, etc.); 2) Suffering from active skin inflammation; 3) Abnormal skin sensation; 4) The presence of metal stents or other metal implants; 5) Significant muscle atrophy/excessive weakness; 6) Having perforations or tattoos.
Within the past 30 days, have received any form of facial skin grinding, chemical peeling, laser freckle removal, or IPL treatment.
Within the past 90 days, the treatment area has received autologous fat grafting, fractional laser, fillers, botulinum toxin therapy, liposuction, or other types of radiofrequency therapy.
Within the past 6 months, have received traction therapy;
There is a history of medication or concomitant medication during the study period, including:
1) Take nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, etc. within 10 days before treatment or within 3 days after treatment; 2) Take acetaminophen within 24 hours before treatment; 3) Antiplatelet therapy should be administered within 72 hours prior to treatment; 4) Perform anticoagulant therapy within 2 weeks before or during treatment; 5) Local steroid therapy within 4 weeks prior to treatment and during the study period, or systemic corticosteroid therapy within 6 months prior to treatment; 6) Administer immunosuppressive drugs within 6 months prior to treatment and during the study period.
⑧ History of allergies to the required materials and ingredients during the treatment process.
⑨ Individuals who are currently participating or have participated in clinical trials of other medical devices or drugs within the past 90 days.
⑩ Pregnant women, lactating women, or those with fertility plans during the trial period.
⑪ Those with severe mental illness who cannot cooperate.
⑫ The researchers believe that participants are not suitable for this experiment.
Device: Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinkles
Device: The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinkles
The instrument used is a similar product that has already been launched on the market
The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinkles
Main effectiveness indicators
Overall clinical efficacy rate，Using the Fitzpatrick Skin Wrinkle and Elasticity Rating Scale, a four level evaluation was conducted on the improvement rate of wrinkles before and after treatment, based on the pre-treatment baseline: significant improvement, moderate improvement, mild improvement, and no improvement. ① Significant improvement: Wrinkle improvement rate\>75%; ② Moderate improvement: The wrinkle improvement rate is between 51% and 75%; ③ Mild improvement: The wrinkle improvement rate is between 25% and 50%; ④ No improvement: Wrinkle improvement rate\<25%. Overall clinical efficacy rate=(number of significantly improved cases+number of moderately improved cases+number of mildly improved cases)/total cases.
Time frame: 90 days after treatment
Main safety indicators
Measure the respiratory frequency of the subject using a pulmonary function meter，in beats per minute
Time frame: Before and immediately after treatment
Main safety indicators
Adverse event incidence rate
Time frame: Before intervention, during treatment, and 90 days after treatment
Secondary effectiveness indicators
VISIA Facial Rating
Time frame: On the 7th, 30th, and 90th day after treatment
Secondary effectiveness indicators
Visual Analogue Scale
Time frame: Immediately after treatment
Secondary effectiveness indicators
Skin reaction score
Time frame: Immediately after treatment, 7 days after treatment
Secondary effectiveness indicators
Using a satisfaction rating scale，Calculate the proportion of satisfied patients
Time frame: 90 days after treatment
Main safety indicators
Using a thermometer to measure the patient's body temperature，Body temperature unit Celsius
Time frame: Before and immediately after treatment
Main safety indicators
Measure the subject's pulse using a pulse oximeter, in beats per minute
Time frame: Before and immediately after treatment
Main safety indicators
Measure the subject's blood pressure using a sphygmomanometer, in mmHg
Time frame: Before and immediately after treatment
Secondary safety indicators
Equipment failure rate
Time frame: Immediately after treatment
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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