Neck wrinkles
Conditions
Interventions
experimental group:Sodium Hyaluronate Compound Solution for Injection
Control Group:Sodium Hyaluronate Compound Solution for Injection
Sponsors
Beijing Friendship Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female at the age of 18~70 years; 2.Volunteers whose neck wrinkles are obvious, requiring stuffing and repairing operation; 3.The intensity of neck wrinkles are classified from moderate to severe, according to the ATNLS; 4.Subjects are willing to take part in the test and sign Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant or breastfeeding or who are going to become pregnant during the trial; 2. There are obvious acne scars and active skin diseases in the neck area, such as infections, local wounds, psoriasis and herpes simplex, etc.; cancerous or precancerous lesions or unhealed wounds; 3. Other types of wrinkle treatments have been performed within 24 weeks before the neck area injection, such as botox treatment (Botox injection), laser skin resurfacing, grinding, chemical peeling, etc.; 4. Being receiving immunosuppressive therapy during the screening period; 5. Subjects who are taking anticoagulant or antiplatelet drugs (such as aspirin, heparin, warfarin, etc.) within or within 2 weeks of the injection; 6. Abnormal blood coagulation function; 7. Subjects with a history of head and neck radiation therapy within one year before the study; 8. People with scar constitution; 9. There is a history of serious diseases of important organs (cardiovascular system, liver, lung, nervous system, kidney, etc.), or a history of abnormal immune function (such as autoimmune disease, low immune function); 10. Participants in clinical trials of other drugs or medical devices within 12 weeks before screening; 11. A history of severe allergic reactions, a history of genetic allergies, a history of known allergies to hyaluronic acid products or any ingredient in this product, or severe allergic reactions to multiple substances, showing severe allergic reactions; 12. The investigator believes that it is not suitable for participants, such as participation in the trial may put the participants at a significant risk, may confuse the results of the study, the participants have unrealistic expectations or have obvious psychological disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neck wrinkle score (ATNLS) at the 4th week after the last injection and the difference in ATNLS improvement rates between the two groups ;The rate of improvement in the Subject's Global Aesthetic Improvement Scale (S-GAIS) score at different follow-up time points; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ATNLS scores and the corresponding improvement rates measured at baseline before the second injection, baseline before the third injection, and at 12 and 24 weeks after the final injection.; | — |
Countries
China
Contacts
Public ContactLi Linfeng
Department of Dermatology, Beijing Friendship
Outcome results
None listed