Suitable for facial dermal tissue filling to correct dynamic forehead wrinkles.
Conditions
Interventions
A Group :Group A: Subjects voluntarily sign an informed consent form. According to the order in which they enter the study, the first case or the first two cases of eligible subjects screened by each
Group B: Experimental Group:Experimental device treatment
Group B: Control Group:Comparative Device Therapy
Sponsors
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, any gender; 2. The investigator will assess the participant's forehead wrinkles on site, with a WSRS severity score of moderate or severe (grade 3 or 4); 3. Voluntarily willing to participate in the clinical trial and agree to sign a written informed consent form. Note: All of the above criteria must be met to be eligible.
Exclusion criteria
Exclusion criteria: 1. There are skin atrophy, tattoos, scars, pigmentation, active inflammation, infection, cancerous or precancerous lesions, unhealed wounds, herpes, etc. in the treatment area that affect treatment and efficacy evaluation as judged by the injection investigator; 2. Received before screening or planned to undergo the following surgeries or treatments affecting this trial during the trial: (1). Prior to screening or planned during the trial: eyebrow lift, facial lift, non-absorbable thread lift, fat injection in the area to be treated, or implantation of permanent facial fillers (such as polymethyl methacrylate, silicone, PTFE, etc.); (2).Within 24 months before screening or planned during the trial: semi-permanent dermal filler injection (such as calcium hydroxyapatite, poly-L-lactic acid, polycaprolactone, etc.) or implantation of absorbable wires (such as poly-p-dioxanone wire, poly-L-lactic acid thread, etc.) in the area to be treated; (3).Within 12 months before screening or planned during the trial: injection of degradable dermal fillers (such as hyaluronic acid, collagen, etc.) in the area to be treated; (4).Within 6 months before screening or planned to be performed during the trial: Botox toxin, mesotherapy, energy devices (such as laser, radiofrequency, ultrasound, etc.) in addition to photomodulation therapy and intense pulsed light in the treatment area, dermabrasion, chemical peeling or other ablative treatments (such as trichloroacetic acid, carboxic acid, fruit acid with a concentration of 10% or above, or salicylic acid with a concentration of 2% or above, etc.); (5).Within 3 months before screening or planned during the trial: photomodulation therapy, intense pulsed light, superficial exfoliation or other ablative treatments (such as fruit acid concentration below 10% or salicylic acid concentration below 2%, etc.) in the treatment area. 3.Subjects have a history of abnormal coagulation function, or have used or plan to use anticoagulant, antiplatelet, or thrombolytic therapy (such as warfarin, aspirin, etc.) within 14 days before screening; 4.Those with a history of keloids; 5. Those who have a history of multiple severe allergies or hereditary allergies and plan to undergo desensitization treatment during the trial; or subjects who are allergic to the components of the drugs or devices used in the trial treatment method (including lidocaine or other amide-based local anesthetics, collagen, silk fibroin protein, porcine products, etc.); 6.As judged by the injecting investigator, the visual acuity level of the subject when not wearing glasses (contact lenses can be worn) is insufficient to complete the efficacy self-assessment; 7.Pregnant women, lactating women, or those who have a birth plan during the trial; 8.Participation in other interventional clinical trials within 1 month before screening; 9.The subject has serious systemic diseases (infectious diseases, history of skin malignant diseases, immune dysfunction, autoimmune diseases, acute inflammation or infection, uncontrolled diabetes, malignant tumors, etc.), severe psychological disorders, mental illnesses, visual impairments, etc., as judged by the injecting investigator, and the abnormal laboratory test results are determined by the injecting investigator to be enrolled; 10.Subjects who are unable to communicate or do not follow the instructions; 11.Other situations that the investigator believes are not suitable for participating in this trial; Note: Only thos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle Severity Rating Scale,WSRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| On-site, blinded-assessor WSRS-based treatment efficacy rate for forehead wrinkles;The effective rate of forehead wrinkle treatment evaluated on-site by injection researchers using WSRS;Global Aesthetic Improvement Scale,GAIS;The improvement rate of the global cosmetic effect Grading (GAIS) for forehead wrinkles evaluated by the subjects;Satisfaction rate as assessed by the subjects;Visual Analogue Scale,VAS; | — |
Countries
China
Contacts
Public ContactZhao Hongyi
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Outcome results
None listed