Nasolabial folds
Conditions
Interventions
experimental group:amalian SF 16 fine hyaluronic acid gel for injection
Sponsors
Plastic Surgery Hospital(institute), CAMS, PUMC
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years old; 2. Those who have nasolabial fold wrinkles (WSRS score is 2~3) and are willing to receive treatment of correction; 3. Agree not to receive any facial cosmetic treatments other than the experimental treatment during the trial period; 4. Sign the informed consent form and agree to participate in all visits, inspections and treatments in accordance with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Those who have received silicone or other permanent filler filling treatment in the nasolabial fold area in the past, or the filler used in the filling treatment is unknown; 2. Those who have received hyaluronate acid gel injection in the nasolabial fold area in the past year; 3. Those who have undergone other surgical treatments to improve facial wrinkles, such as facial lift surgery or thread lift surgery; 4. Those who have received treatments such as radiofrequency, laser, botox injection, chemical ablation and liquid nitrogen cryotherapy to eliminate or reduce facial wrinkles in the past 6 months; 5. Those who have precancerous lesions or have a tendency to become cancerous on the facial skin, or those who have received partial radiation therapy on the facial skin; 6. The nasolabial fold wrinkles have been significantly hardened and cannot disappear by stretching; 7. Those who have active skin diseases such as facial infections, arthritis, herpes, psoriasis; 8. Those who have autoimmune diseases or are receiving immunotherapy; 9. Those who have coagulopathy or using anticoagulant/antiplatelet drugs; 10. There are one or more abnormalities in blood routine, urine routine, liver function, and renal function (except those that the investigator judges are not clinically significant); 11. Those who have scar constitution, or easy to form keloid, or hypertrophic scar; 12. Women who are planning to become pregnant or breastfeeding; 13. Those who are allergic to hyaluronate acid or other materials involved in this trial; 14. Those who are still participating in other clinical trials within the past 3 months; 15. Those who have psychosis or currently taking antipsychotic drugs; 16 .Participating in this trial is not suitable by the judgement from the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Rate of Rrinkle Correction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wrinkle Severity Rating Scale;Global Aestheyic Improvement Scale;Maintenance Time of Wrinkle Improvement;Incidence of Remedial Treatment; | — |
Countries
China
Contacts
Public ContactQi Zuoliang
Plastic Surgery Hospital(institute), CAMS, PUMC
Outcome results
None listed