Facial skin wrinkles
Conditions
Interventions
Test group:Use facial radiofrequency system for 3 treatments
control group:No treatment
Sponsors
The First Affiliated Hospital, the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 70 years old (including threshold), regardless of gender; (2) Fitzpatrick's skin classification is II-IV type.There is a need to reduce facial wrinkles and improve facial skin firmness, and (evaluated by blind researchers) the Fitzpatrick Wrinkle and Elastic Tissue Degeneration Scale (FWCS) scores>3 points; (3) Voluntarily participate in this clinical trial and sign the subject's informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with acute or progressive skin diseases (including but not limited to acne, contact dermatitis, atopic dermatitis, psoriasis, vitiligo, etc.), active skin infections, herpes, or open wounds in the intended treatment area of the face; (2) Has a history of severe skin allergies, and the subject is in the active phase of skin allergies; (3) Individuals who have had skin exposure within the past week (such as sunbathing or outdoor workers); (4) Screening for individuals who have undergone plastic surgery or other cosmetic procedures on the intended facial area or overall area within the first 3 months that may affect the effectiveness of facial treatment (including optoelectronic therapy such as intense pulsed light, dot matrix laser, non-invasive radio frequency, etc.); (5) Individuals who have undergone deep chemical exfoliation surgery within one month prior to screening; (6) Individuals who have received temporary injections of cross-linked sodium hyaluronate or collagen or other fillers on the face within the 12 months prior to screening, or those who have received injections of non cross-linked sodium hyaluronate or botulinum toxin on the face within the 6 months prior to screening; (7) Screening for individuals who have used or plan to use retinoic acid drugs within the first 6 months of treatment; (8) Those who have used or plan to use immunosuppressive drugs within the past week before and after treatment; (9) Individuals with scar constitution; (10) Those who have bleeding tendency or have used thrombolytic agents, anticoagulants (such as heparin, warfarin, sodium citrate, aspirin, etc.) or platelet coagulation inhibitors within 2 weeks, or are accompanied by autoimmune diseases (such as rheumatism, lupus erythematosus, etc.), immune dysfunction, diabetes or malignant tumors and other serious systemic diseases; (11) Patients with clinically significant liver and kidney dysfunction during the screening period (AST, ALT, or Cr>1.5 times the upper limit of normal value); (12) Individuals with metal implants, implanted pacemakers, defibrillators, or any other type of electrical device in the area to be treated; (13) Patients with facial nerve injury, inability to feel heat, facial muscle spasms, or temporomandibular joint disorders; (14) Pregnant and lactating women, or those who plan to conceive during the study period; (15) Individuals who have participated in other intervention clinical trials within the month prior to the start of this trial; (16) Researchers believe that other individuals are not suitable for participating in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of improving facial skin wrinkles 3 months after the last treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Using VISIA skin detector to measure changes in facial skin values before and after treatment;Blind researcher Fitzpatrick Wrinkle and Elastic Tissue Degeneration Scale (FWCS) score;Using a 3D system to measure changes in facial parameters before and after treatment;Treatment Researchers Score Global Cosmetic Efficacy (GAIS);Subject's Global Beauty Effectiveness (GAIS) score;Pain score;Subject satisfaction rating;Performance evaluation of device operation; | — |
Countries
China
Contacts
Public ContactGao Lin
The First Affiliated Hospital, the Air Force Medical University
Outcome results
None listed