Facial wrinkles
Conditions
Interventions
experimental group:Experimental instrument therapy
control group:Control instrument treatment
Sponsors
peking university shenzhen hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Adults aged 18-65 (including threshold values), regardless of gender; (2) Fitzpatrick skin types II-IV; (3) Facial wrinkles: Fitzpatrick Wrinkles and Elasticity Scale (FWES) score = 3 and = 6; (4) Individuals in need of improving facial wrinkles; (5) Voluntarily accept treatment, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Tattoos, scars, deformities, unhealed wounds, active skin diseases (such as active rashes, severe acne, cystic nodules, etc.) or inflammatory skin diseases (such as eczema, contact dermatitis, atopic dermatitis, etc., except for acne vulgaris) that may affect the evaluation of efficacy or increase the risk of treatment exist in the area to be treated. In the advanced stage or infectious skin diseases (such as bacterial skin diseases, viral skin diseases, fungal skin diseases, parasitic infectious skin diseases, etc.), psoriasis, vitiligo, malignant tumors or precancerous lesions, etc. (2) Prior to screening, have undergone or planned to undergo the following surgeries or treatments that may affect this trial during the trial period: a. Before screening or during the trial period, planned procedures include facial lifting, non absorbable wire embedding and lifting, injection of fat into the treatment area, or implantation of permanent facial fillers (such as polymethyl methacrylate, silicone, polytetrafluoroethylene, etc.) or unknown injections; b. Planned within 24 months prior to screening or during the trial period: injection of semi permanent skin fillers (such as hydroxyapatite calcium, polylactic acid, polycaprolactone, etc.) or implantation of absorbable wires (such as poly-p-dioxanone wire, polylactic acid wire, etc.) into the treatment area; c. Planned within the 12 months prior to screening or during the trial period: injection of degradable skin fillers (such as cross-linked hyaluronic acid, collagen, etc.) into the treatment area; d. Within the first 6 months of screening or during the trial period, planned treatments include botulinum toxin injection, non crosslinked hyaluronic acid injection filling, cosmetic therapy (including water light needle), energy devices other than light modulation therapy and intense pulsed light (such as laser, radio frequency, focused ultrasound, etc.), skin grinding, medium depth or greater depth chemical exfoliation, or other exfoliative treatments (such as trichloroacetic acid, bicarbonate, 10% or higher concentration fruit acid or 2% or higher concentration salicylic acid, etc.) in the area to be treated; e. Within the first 3 months of screening or planned during the trial period: the area to be treated will receive light modulation therapy, intense pulsed light, superficial peeling surgery, or other peeling treatments (such as 10% or less concentration of fruit acid or 2% or less concentration of salicylic acid, etc.); f. Planned within one month prior to screening or during the trial period: receive systemic treatment with retinoic acid or glucocorticoids (excluding inhaled forms). (3) According to researchers' assessment, individuals with severe immune system diseases, active hyperthyroidism, or immune system damage caused by immunosuppressive diseases or the use of immunosuppressive drugs are expected to have an increased risk of treatment. (4) At present, there are patients with coagulation dysfunction (APTT>1.5 times the upper limit of laboratory normal value) or those who are currently using anticoagulant drugs (such as warfarin, aspirin, etc.), which have been determined by researchers to increase the risk of treatment at the site to be treated. (5) Individuals with past or current facial nerve paralysis. (6) Patients with severe medical diseases, such as severe heart disease, poorly controlled diabetes and its complications, and severe liver and kidney diseases, are not suitabl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Scale (GAIS); | — |
Countries
China
Contacts
Public ContactBo Yu
peking university shenzhen hospital
Outcome results
None listed