Skin wrinkles
Conditions
Interventions
Treatment group:Received facial treatment with ReactionTMFC/ST radiofrequency therapy device once every 3 weeks for four consecutive sessions
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Age is 18-60 years old and gender is not limited. 2) FWS score II. 3) Willing and able to follow the protocol requirements, including returning to the hospital for follow-up and not undergoing any other operations in the area to be treated throughout the study follow-up period. 4) Those who agree to sign the informed consent form and are able to follow the medical advice and have regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women or female subjects who are pregnant during the intended trial; 2) History of any skin disease (e.g., herpes, eczema, rash) at the treatment site and any disease that may be triggered by heat exposure. 3) Contraindications as labeled in the instructions. 4) Treatment of tattooed or embroidered areas. 5) Extremely dry or sensitive skin 6) Sunburn on the treated area 7) Suffering from keloids or trauma that is difficult to heal 8) Patients who have had synthetic fillers (e.g. silicone) implanted in the area to be treated are not allowed to be treated. 9) Patients who have received chemical peels or natural filler implants should discontinue treatment at least two weeks before starting ST treatment. 10) Patients should wait at least 3 to 6 months after deep chemical peels and lasers before undergoing ST treatment. 11) Patients who have received Botox injections should avoid any treatment for 5 to 7 days thereafter. 12) In the opinion of the investigator, severe solar elastic tissue degeneration, excessive skin laxity, excessive subcutaneous fat and significant scarring are present in the area to be treated. 13) Psychotropic medications that, in the opinion of the investigator, may interfere with the subject's ability to understand the requirements of the protocol or to understand and sign informed consent. As well as a long history of drug or alcohol abuse. 14) Current smoker, smoker defined: smokes greater than or equal to 1 cigarette per day or quit within the past 6 months. Smoking. Current user of any nicotine-containing product, e.g., e-cigarettes, nicotine gum, nicotine patches, etc. Nicotine patches, etc. 15) Participation in any other clinical trial within 3 months prior to signing the informed consent form; 16) Diseases and treatments that, in the opinion of the investigator, may interfere with the evaluation of the safety or efficacy of the investigational device. Subjects who are poor cooperators, non-compliant with the treatment regimen, or unreliable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fitzpatrick Winkle and Elastosis Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician Global Aesthetic Improvement Scale;Subject Global Aesthetic Improvement Scale; | — |
Countries
China
Contacts
Public ContactWu Yan
Peking University First Hospital
Outcome results
None listed