Wrinkles on the skin
Conditions
Interventions
experimental group:Radiofrequency therapy device
control group:High frequency skin therapy device
Sponsors
Air Force Medical Center, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 (inclusive) years old, gender is not limited; (2) Fitzpatrick wrinkle and elasticity score >= 3 points; (3) Fitzpatrick's skin type is type II-IV; (4) Have the willingness to reduce facial skin wrinkles and have a reasonable expectation of the treatment effect; (5) Voluntarily signed informed consent and willing to comply with all study procedures and visit arrangements.
Exclusion criteria
Exclusion criteria: (1) Severe infection, open injury, inflammatory skin disease (such as dermatitis, eczema, acne, etc.) or other suspicious lesions on the face; (2) There are tattoos or abnormal pigmentation in the area to be treated, which affects the evaluation of wrinkles; (3) There are metal, silica gel, PTFE, polymethyl methacrylate, fat and other implants in the area to be treated; (4) There is a pacemaker, defibrillator or any other electronic or metal implant in the body; (5) Active infection in the body or herpes simplex virus infection; (6) Skin diseases with homomorphic reactions, such as vitiligo, psoriasis, lichen planus, flat warts, etc.; (7) Clinically significant abnormal coagulation function or need to take anticoagulant drugs (such as aspirin, warfarin, clopidogrel, etc.) for a long time; (8) Positive test for hepatitis B, hepatitis C, syphilis, and AIDS; (9) History of severe allergy or allergy to the contact site of the research device and anaesthetic; (10) History of scar constitution or keloid; (11) Severe systemic diseases, such as cardiovascular diseases, liver and kidney diseases, autoimmune diseases, diabetes mellitus and poorly controlled hypertension, etc.; (12) Malignant tumour within 5 years prior to enrolment; (13) Epilepsy, psychiatric illness, or taking antipsychotic medications; (14) Pregnant, lactating females or unable to take effective contraceptive measures during the test or having a birth plan during the test; (15) Predicted increase or decrease in BMI >=2 kg/m2 during the test; (16) Sunburned skin or excessive tanning within 2 weeks before enrolment; (17) Received systemic treatment with glucocorticoids, immunosuppressants, tretinoins and other drugs within 6 months before enrolment; (18) Received facial chemical peel, intense pulsed light, ultrasound, laser, radiofrequency, radiotherapy, dermabrasion and botulinum toxin injection within 6 months before enrolment; (19) Received facial plastic surgery, liposuction, thread lifting, hyaluronic acid, collagen filling, etc. within 12 months before enrolment; (20) Received facial calcium hydroxyapatite, polycaprolactone, polylactic acid filler and other treatments within 36 months before enrolment; (21) Participated in other interventional clinical trials within 30 days before enrolment; (22) Other conditions that the investigator considers unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fitzpatrick Wrinkle and Elastosis Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject satisfaction;Pain score;GAIS score improvement rate; | — |
Countries
China
Contacts
Public ContactHong Cai
Air Force Medical Center, PLA
Outcome results
None listed