crow's feet wrinkles
Conditions
Interventions
Trial Group:Investigational product: Injectable Type I Collagen Solution
Control group:Control product: Injectable Recombinant Human-Type III Collagen Solution
Sponsors
Chongqing Xingrong Plastic Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-65 years (inclusive), gender not limited; 2. Individuals with a Wrinkle Severity Rating Scale (WSRS) score >=3 based on bilateral crow's feet assessed by the evaluator and who wish to correct their wrinkles; 3. Able to complete the relevant assessments during the trial without wearing eyeglasses; 4. Willing to sign an informed consent form, fully understanding the trial content, process, and possible adverse reactions, and agreeing to participate in all visits, examinations, and treatments as required by the trial protocol.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women, or women planning to become pregnant during the trial; 2.Women with severe mental disorders, psychological disturbances, personality disorders, or currently taking antipsychotic medications; 3.Women with acute allergic or inflammatory skin conditions (such as dermatitis, eczema, acne, seborrheic dermatitis, rosacea), unhealed wounds, precancerous lesions, or cancer on the face; 4. Women with systemic infections; 5. Women with coagulation disorders or who have taken anticoagulants or antiplatelet drugs (such as aspirin, heparin, warfarin, etc.) within 2 weeks prior to injection. ; 6. History of serious disease affecting vital organs (cardiovascular system, liver, lungs, nervous system, and kidneys, etc.) or history of abnormal immune function (such as autoimmune diseases or immunodeficiency); 7. History of hypertrophic scars or keloids; 8. Allergy to porcine protein, collagen-like substances, or any component of this product, allergy to local anesthetics (such as lidocaine or other amide-based anesthetics), or a history of severe or multiple allergies; 9. Previous treatment of the upper face or planned treatment of the following during the study period: 10. Has undergone fat grafting or implanted permanent fillers, such as polymethyl methacrylate, silicone, or polytetrafluoroethylene;Has received semi-permanent fillers, such as calcium hydroxyapatite or poly-L-lactic acid, within 36 months prior to enrollment; Has received temporary fillers, such as cross-linked sodium hyaluronate, within 18 months prior to enrollment; Has undergone non-invasive skin tightening (such as Ultherapy or Thermage) or facial wrinkle removal within 12 months prior to enrollment; Has received injections of non-cross-linked sodium hyaluronate, collagen, or botulinum toxin within 6 months prior to enrollment; 10.Has received any other clinical trial product within 30 days prior to enrollment or plans to participate in other clinical trials during the study period; 11) Has any other circumstances deemed unsuitable for participation in this clinical trial by other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of correcting crow's feet wrinkles 3 months after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effectiveness rate of correcting crow's feet wrinkles according to EI evaluation.;Improvement in crow's feet wrinkles based on WSRS scores in the EI evaluation.;Treatment Investigator (TI) assessed overall aesthetic satisfaction;Study participant-assessed overall aesthetic satisfaction;Study participants assessed injection-related pain immediately and at 30 minutes post-injection.; | — |
Countries
China
Contacts
Public ContactLi Shirong
Chongqing Xingrong Plastic Surgery Hospital
Outcome results
None listed