Moderate to severe wrinkles on the neck
Conditions
Interventions
Experimental group:Using injectable agarose gel produced by Shanghai Beirong Biogenetic Engineering Co., Ltd
Control group:Using injectable sodium hyaluronate compound solution produced by Imeik Technology Development Co., Ltd.
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Males or females aged between 18 and 60 (inclusive); 2. With moderate or severe neck lines, rated as 2 or 3 on the Anterior Neck Lines Severity (ATNLS) scale; 3. Willingly participating in this clinical trial and having signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. During the screening period, the presence of infections, pathologies, inflammations, dermatological conditions (such as acne, psoriasis, herpes, etc.), cancers, precancerous conditions, or unhealed wounds on the neck. 2. Individuals with hemorrhagic diseases or coagulation disorders, or those who have undergone anticoagulant, antiplatelet, or thrombolytic treatment (e.g., warfarin, heparin, aspirin, etc.) within the past two weeks. 3. Subjects with the following diseases deemed unsuitable for enrollment by the investigator: malignant tumors or severe dysfunction of vital organs (such as the brain, heart, lungs, liver, kidneys, etc.), including severe cardiovascular and cerebrovascular diseases (e.g., hospitalization for myocardial infarction or heart surgery within the past 3 months, history of congestive heart failure or myocardial infarction, severe unstable arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysms, strokes, etc.), severe lung diseases (e.g., moderate to severe pneumonia, respiratory failure, etc.), uncontrolled diabetes, epilepsy, liver function abnormalities (serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN)), renal function abnormalities (creatinine (Cr) > 1.5 times ULN). 4. Individuals positive for HIV antibody (Anti-HIV), syphilis antibody (TPHA/RPR), hepatitis C antibody (Anti-HCV), or hepatitis B surface antigen (HBsAg). 5. Subjects currently undergoing chemotherapy or radiotherapy. 6. Subjects with mental illness or emotional instability. 7. Subjects with immune system disorders, such as primary immunodeficiency diseases, secondary immunodeficiency diseases, autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.), or those receiving immunosuppressant treatment during the screening period. 8. Subjects who have received cross-linked sodium hyaluronate or other temporary fillers in the neck area within the past 12 months, or non-cross-linked sodium hyaluronate filler treatment within the past 6 months. 9. Subjects who have received permanent fillers (e.g., polymethyl methacrylate, silicone, polytetrafluoroethylene, etc.), semi-permanent fillers (e.g., calcium hydroxylapatite, poly-L-lactic acid, polycaprolactone, etc.), or autologous fat grafting in the neck area. 10. Subjects who have received or plan to receive treatments aimed at skin rejuvenation, such as laser, radiofrequency ablation, microfocused ultrasound, or botulinum toxin injections, in the neck area within the past 6 months or during the trial period. 11. Subjects who have undergone or plan to undergo surgeries in the neck or facial area that may affect the assessment of neck wrinkle efficacy. 12. Individuals with known allergies to agarose gel, hyaluronic acid, or any components of the test or control devices, or allergies to any local anesthetics (e.g., lidocaine or any other anesthetic drugs), or with a history of severe allergic reactions or anaphylactic shock. 13. Individuals with a tendency to form scars, or with scars, tattoos, or pigmentation on the neck area that may affect visual assessment. 14. Pregnant or lactating women, or women who have not used effective contraception in the past month or are unwilling to use effective contraception during the entire trial period, as well as men or women unwilling to use effective contraception. 15. Subjects who have participated in clinical trials within the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of the severity grading of neck lines (using the Allergan Neck Lines Scale, ATNLS) as assessed by blinded evaluators using photographs at 4 weeks after the last injection.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change value of ATNLS evaluated by blind evaluators through photos;Improvement rate of ATNLS evaluated by blind evaluators through photos;Improvement rate of overall aesthetic effect (GAIS) evaluated on-site by injection evaluators;Improvement rate of overall aesthetic effect (GAIS) evaluated by subjects;Subject satisfaction evaluation; | — |
Countries
China
Contacts
Public ContactXu Wei
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed