Perioral wrinkles
Conditions
Interventions
Low-dose Collagen Group:Recombinant type III humanized collagen lyophilized fiber (Colnet) 12mg + normal saline 3ml, formulated to 4mg/ml, linear retrograde injection into dermis
Medium-dose Collagen Group:Recombinant type III humanized collagen lyophilized fiber (Colnet) 12mg + normal saline 2ml, formulated to 6mg/ml, linear retrograde injection into dermis
High-dose Collagen Group:Recombinant type III humanized collagen lyophilized fiber (Colnet) 12mg + normal saline 1.5ml, formulated to 8mg/ml, linear retrograde injection into dermis
Normal Saline Control Group:Normal saline 2ml, visually identical to experimental drug, linear retrograde injection into dermis
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years inclusive, any gender; 2. Voluntarily sign the informed consent form and commit to completing the 12-month follow-up; 3. Moderate to severe perioral wrinkles confirmed by an independent blinded assessor (Wrinkle Severity Rating Scale, WSRS score: baseline score >= Grade 3); 4. No active skin lesions such as acne, dermatitis, or hypertrophic scars; 5. Normal laboratory results for liver and renal function (ALT =150×10^9/L, hemoglobin >=110 g/L; 7. For subjects with previous perioral filler/photoelectric treatment, the following washout periods must be met: (1) Hyaluronic acid/collagen filler: >=12 months; (2) Botulinum toxin treatment: >=6 months; (3) Energy-based treatments (laser, radiofrequency, etc.): >=3 months; 8. Agree not to receive additional anti-aging treatments during the study period.
Exclusion criteria
Exclusion criteria: 1. Severe systemic diseases (diabetes, immunodeficiency disorders, malignant tumors, etc.); 2. Coagulation disorders or long-term use of anticoagulants (aspirin, warfarin, etc.); 3. Pregnant or lactating women; 4. Known hypersensitivity to collagen, lidocaine, or excipients in the investigational product; 5. Active perioral inflammation such as herpes, acne, eczema, skin breakdown or infection at the injection site; 6. Unable to refrain from excessive perioral muscle movement interventions; 7. Mental disorders or inability to comply with follow-up; 8. Alcoholism, drug abuse, or other behaviors that may impair wound healing; 9. Severe facial asymmetry or scars that interfere with wrinkle assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioral Wrinkle Severity Rating Scale (WSRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject Global Aesthetic Improvement Scale (Subject GAIS);Investigator Global Aesthetic Improvement Scale (Investigator GAIS);3D Skin Imaging Parameters;Rescue Injection Rate; | — |
Countries
China
Contacts
Public ContactLi Jingyi
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed