Neck wrinkles
Conditions
Interventions
Experimental Group:Injection test products
control group:Treatment of neck wrinkles with Hi-Body injection
Sponsors
Chongqing Xingrong Plastic Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old (inclusive), regardless of gender; 2. Those whose ATNLS score of cervical transverse lines is 2 to 3 as assessed by the researchers and wish to correct them; 3. Agree not to undergo other neck cosmetic treatments during the trial, such as thermolift, Thermage lifting, etc.; 4. Voluntarily sign the informed consent form, fully understand the content, process and possible adverse reactions of the trial, and agree to participate in all visits, examinations and treatments in accordance with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. The ATNLS score of the neck creases assessed by the investigator is 0, 1 or 4; 2. Pregnant or lactating women or female subjects who plan to become pregnant during the trial; 3.Those with tattoos, piercings, pigmentation, previous trauma, or deformities that interfere with the neck; 4. Thyroid cancer, thyroid-related diseases, or a history of neck radiation; 5. Those with acute allergic or inflammatory skin diseases (such as acute dermatitis, eczema, acne, seborrheic dermatitis, rosacea), unhealed wounds, infections, precancerous lesions, or cancer on the neck; 6. Those with systemic infections; 7.Abnormal coagulation function or taking anticoagulant or antiplatelet drugs (such as aspirin, heparin, warfarin, etc.) within 2 weeks before injection; 8. Those with a history of serious diseases of important organs (cardiovascular system, liver, lungs, nervous system, and kidneys, etc.), or a history of abnormal immune function (such as autoimmune diseases, immunosuppression); 9.Laboratory tests indicate ALT>2×ULN or AST>2×ULN or Ccr=60 ml/min or BUN>2×ULN; 10. People with scar constitution; 11. People with a history of severe allergic reactions, a history of hereditary allergies, a history of known allergies to hyaluronic acid products or any ingredients in this product, lidocaine or topical anesthetics, or severe allergic reactions to multiple substances, showing severe hypersensitivity reactions; 12. Those who have had the following previous treatments or plan to undergo the following cosmetic treatments during the study: fat filling or permanent fillers implanted in the neck, such as polymethyl methacrylate, silicone, and polytetrafluoroethylene; Within 36 months before enrollment, semi-permanent fillers were filled in the neck, such as calcium hydroxyapatite and poly-L-lactic acid; Within 12 months before enrollment, temporary fillers were filled in the neck, such as sodium hyaluronate and collagen; Within 6 months before enrollment, botulinum toxin was injected into the neck, or the neck received laser or energy device treatment, grinding, chemical peeling, water injection, and mesotherapy; 13. Participated in other drug or medical device clinical trials within 30 days before screening; 14. There are other situations that are judged by other researchers as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of correcting cervical creases 3 months after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness of correcting cervical creases 1 month and 6 months after the last injection (EI evaluation);Improvement of ATNLS scores of cervical creases 1 month, 3 months, and 6 months after the last injection; | — |
Countries
China
Contacts
Public ContactLi Shirong
Chongqing Xingrong Plastic Surgery Hospital
Outcome results
None listed