Temporal depression
Conditions
Interventions
Control group :None
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. No gender restriction, age 18-65 (inclusive); 2. The temporal depression scale was rated as mild, moderate and severe (2, 3 and 4 points); 3. People who need to improve temporal depression; 4. Able and willing to follow the investigator's instructions, follow the medication and treatment restrictions specified in this protocol, and complete all visits for this study as required; 5. Voluntarily participate in the clinical trial and sign the subject informed consent.
Exclusion criteria
Exclusion criteria: 1. During the screening period, patients with infection, lesion, inflammation, skin disease around the intended injection site of the temporal part, as well as patients with a history of head radiotherapy, cancerous or pre-cancerous lesions; 2. Have received permanent or semi-permanent fillers (such as calcium hydroxyapatite, polyl-lactic acid, polymethyl methacrylate, silicone, expanded polytetrafluoron, polycaprolactone, etc.) in the temporal region; 3. Other temporary fillers such as crosslinked hyaluronic acid or collagen injection therapy were used in the temporal region within 12 months, or non-crosslinked hyaluronic acid was injected in the temporal region within 6 months before enrollment; 4. Patients who performed plastic surgery or cosmetic operations in the temporal injection area or the middle and upper face 6 months before screening or planned to do so during the study period (such as facial lifting, botox injection, etc.) that may affect the evaluation of depression efficacy; 5. Evaluators with temporal scars that affect visual effects; 6. Patients who are allergic to hyaluronic acid or lidocaine local anesthetics in the past and have a history of severe allergic reaction; 7. Patients with platelet count less than 50×10^9/L or abnormal coagulation mechanism (APTT > 1.5 times the upper limit of normal value) during the screening period, or who have received anticoagulant, antiplatelet or thrombolytic therapy (such as warfarin, aspirin, etc.) within 2 weeks; 8. Patients with abnormal liver and kidney function (AST, ALT > 1.5 times the upper limit of normal value or Cr > the upper limit of normal value), or autoimmune diseases, such as rheumatism, lupus erythematosus, or immune dysfunction during the screening period; 9. Received chemotherapy, immunosuppressants, immunoregulatory therapies (such as monoclonal antibodies) or systemic corticosteroids (other than inhaled corticosteroids) within 3 months prior to screening; 10. Patients who have had a history of orthodontic treatment within 6 months prior to screening or plan to have orthodontic treatment during the trial period; 11. Pregnant or lactating women, or those planning to become pregnant during the study period; 12. Participants who participated in other interventional clinical trials within 1 month before this study; 13. Participants considered inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of temporal depression 6 months after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| The volume change of the temporal depression area (left and right sides added together) compared with the baseline was analyzed by 3D digital imaging;Blind researcher temporal depression scale score;Injection investigator temporal depression scale score;Global Aesthetic Effect (GAIS) rating by injection investigators;Subjects' ratings of global Beauty Effect (GAIS);NRS pain score; | — |
Countries
China
Contacts
Public ContactWenyu Wu
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed