It is suitable for injection of facial supraperiosteal plane and/or subcutaneous adipose tissue to correct mild to moderate mental retraction.
Conditions
Interventions
control group:None
experimental group:Crosslinked Sodium Hyaluronate Gel for Injection with Lidocaine
Sponsors
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender; 2. Subjects willing to receive chin filling treatment; 3. According to the evaluation of blind researchers, the subjects had mild to moderate to severe chin retraction (i.e. CACRS score 1-3 points); 4. Voluntarily sign an informed consent form, understand and accept the duration of the study, be able and willing to comply with all requirements, including scheduled treatment, follow-up, and other research procedures.
Exclusion criteria
Exclusion criteria: 1. Known allergies to sodium hyaluronate products or any components in this product; 2. Known allergies to any local anesthetic (such as lidocaine or other amide based anesthetic); 3. Known history of severe allergic reactions and multiple severe allergic reactions; 4. Patients with abnormal coagulation mechanisms during the screening period (activated partial thromboplastin time (APTT)>1.5 times the upper limit of normal values), or those who have received any thrombolytic, anticoagulant, or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks prior to enrollment; 5. The chin has received any permanent or semi permanent filler (such as calcium hydroxyapatite, poly-L-lactic acid, polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, polycaprolactone, etc.), autologous fat, etc; 6. Within 12 months before enrollment, the chin and/or lips have received temporary fillers such as sodium hyaluronate (including water light needle) or collagen injection therapy, facial lift surgery (thread embedding), and other unknown material injections; 7. Within 6 months prior to enrollment, any medical beauty treatment (such as botulinum toxin injection, radiofrequency therapy, ultrasound therapy, laser or chemical rejuvenation surgery, skin grinding surgery, facial lifting surgery (including thread embedding), etc.) has been received in the lower part; 8. The chin has undergone surgery, which has been judged by researchers to affect the efficacy evaluation; 9. Tattoos, perforations, obvious facial hair (such as whiskers), scars, deformities, unhealed wounds, active skin diseases or inflammations or infections (such as herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, etc.), abscesses, oral active or persistent infections, carcinogenesis or precancerous lesions that may affect the efficacy evaluation or increase the risk of treatment; 10. Subjects with active autoimmune diseases or medical history (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.) and porphyria; 11. Subjects with a tendency to form keloids, hypertrophic scars, or any other healing disorders; 12. Have received chemotherapy, immunosuppressive therapy, immunomodulatory therapy (such as monoclonal antibodies) or systemic corticosteroids (excluding inhaled corticosteroids) within 3 months prior to enrollment; 13. According to the judgment of researchers, patients with severe dysfunction of important organs (brain, heart, lungs, liver, kidneys, etc.); Subjects with severe cardiovascular and cerebrovascular diseases, severe pulmonary diseases, liver function (ALT, AST)>2 times ULN, renal function (Cr)>1.5 times ULN, and subjects with uncontrolled diabetes, etc 14. Plan to perform various operations or surgical treatments that affect the contour of the lower part, such as filling, wrinkle correction or surgery, tooth extraction, tooth correction or implantation, or installing dentures, during the study period; 15. The subject was participating in other clinical trials within 3 months prior to enrollment in this trial or is currently participating; 16. Women during pregnancy or lactation; 17. Women of childbearing age who plan to conceive or do not use effective contraceptive methods during the research phase * * (the pregnancy test results of female subjects of childbearing age before the first injection should be negative), and men who plan to conceive or are unwilling to use appropriate contrac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of improvement of chin retraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of improvement of chin retraction; | — |
Countries
China
Contacts
Public ContactQingfeng Li
Outcome results
None listed