Adults seeking correction of periocular crow's feet
Conditions
Interventions
treatment group:Subjects in the experimental group received injection therapy with the investigational device: Injectable Polycaprolactone Facial Filler (Specification: 1 mL/syringe, Manufacturer: DEX
Control group:Subjects in the control group received injection therapy with the control device: Sunmax Collagen Implant I manufactured by Sunmax Biotechnology Co., Ltd. (Registration Certificate No. G
Sponsors
Shandong Yongzhou Fengyou Technology Development Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged >=18 and =2, and Crow's Feet Grading Scale (CFGS) score >=1; At smiling: Wrinkle Severity Rating Scale (WSRS) score >=3, and Crow's Feet Grading Scale (CFGS) score >=2; Inter-side difference in crow's feet scores <=1. 3. Subjects who agree not to undergo any other procedures or treatments that may affect the improvement of periorbital crow's feet wrinkles outside this clinical trial during the study period; who can understand and comply with study instructions; who agree not to receive any other facial surgeries during the study; and who are able to participate throughout the entire trial period. 4. Subjects who voluntarily agree to abstain from any aesthetic procedures inconsistent with the study during the trial period. 5. Subjects who provide voluntary written informed consent to participate in this clinical trial and comply with the follow-up requirements specified in the protocol.
Exclusion criteria
Exclusion criteria: 1: Received thread lifting or botulinum toxin treatment in the treatment area within 24 weeks prior to baseline; or ablative skin resurfacing, laser therapy, microneedling, or chemical peeling within 12 weeks prior to baseline; or absorbable fillers (hyaluronic acid, collagen, etc.) within 48 weeks prior to baseline — any aesthetic procedures that may interfere with study injections and/or evaluations. 2: Previous soft tissue augmentation in the treatment area using any permanent (non-biodegradable, e.g., silicone, polyacrylamide, etc.) or semi-permanent products (i.e., calcium hydroxylapatite, poly-L-lactic acid, or polymethylmethacrylate), lifting sutures, or autologous fat. 3: Subjects with severe ocular diseases including uncontrolled glaucoma, cataracts requiring surgery, active ocular infection, ocular tumor, etc. 4: Subjects with significant facial asymmetry or asymmetry of the periorbital region or eyebrows. 5: Presence of scars or tattoos (including eyebrow tattoos or eyeliner) in or around the treatment area that, in the investigator’s judgment, may interfere with study evaluations. 6: Presence of the following conditions in or adjacent to the treatment area: acute inflammation (e.g., redness, swelling, heat, pain), infection, eczema, moderate-to-severe acne, chronic or recurrent skin diseases (e.g., rosacea, facial psoriasis, herpes zoster), or other dermatological disorders. 7: Presence of facial cancer or precancerous lesions. 8: Planning to undergo facial surgery, ocular surgery (including LASIK), or facial aesthetic procedures (e.g., ablative skin resurfacing, laser therapy, microneedling, chemical peeling, botulinum toxin treatment, or dermal fillers) during the study period. 9: Subjects with hemorrhagic disorders or currently using anticoagulants. 10: Subjects with a current or past diagnosis of any of the following systemic diseases that, in the investigator’s judgment, may affect efficacy evaluation or increase safety risks: a) Cardiovascular system: uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg), congestive heart failure (NYHA class = III); b) Respiratory system: chronic obstructive pulmonary disease (COPD GOLD class = II), moderate-to-severe asthma requiring regular oral corticosteroids; c) Digestive system: active gastric ulcer, ischemic bowel disease, or inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis) in active phase; d) Hepatobiliary system: liver cirrhosis (Child-Pugh class B or higher), active viral hepatitis; e) Endocrine system: uncontrolled diabetes (fasting blood glucose =8.3 mmol/L or HbA1c =8.0%); f) Renal and urinary system: severe renal impairment, long-term hemodialysis, peritoneal dialysis, or renal transplantation; g) Autoimmune diseases: systemic lupus erythematosus (active phase), rheumatoid arthritis requiring immunosuppressive therapy. 11: Any other concurrent medical conditions, treatments, or circumstances that, in the investigator’s judgment, may interfere with the evaluation of the study device’s safety or effectiveness, and/or may place the subject at risk if participating in the study. 12: History of drug abuse or alcohol dependence within 1 year prior to screening. 13: Subjects who participated in another investigational device or drug trial within 3 months before study treatment, or who intend to participate in any other clinical trial during the entire study period (from enrollment to th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle Improvement Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Device Operational Performance;Device Defect;Global Aesthetic Improvement Scale (GAIS) Assessment by Injecting Investigators;Global Aesthetic Improvement Scale (GAIS) Assessment by Subjects;WSRS Assessment by Blinded Third-Party Investigators;CFGS Assessment by Blinded Third-Party Investigators;WSRS Assessment by Blinded Investigators at the Study Site;Vital signs;Electrocardiogram;Injection reaction;Visual acuity examination;CFGS Assessment by Blinded Investigators at the Study Site; | — |
Countries
China
Contacts
Public ContactQi Xiangdong
Director of Plastic and Cosmetic Surgery Department, Zhujiang Hospital of Southern Medical University
Outcome results
None listed