Suborbital depression
Conditions
Interventions
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 65 years old (including threshold), regardless of gender; (2) The Allergan Infrared Hollowing Scale (AIHS), evaluated by blind researchers, rated individuals with moderate to severe infraorbital depression (2-3 levels); (3) Individuals with a need to improve suborbital depression; (4) Voluntarily participate in this clinical trial and sign the subject's informed consent form.
Exclusion criteria
Exclusion criteria: (1) Active or recurrent infection in any eye; (2) Scars around the intended injection site under the orbit, active skin disease or inflammation or infection (such as acne, dermatitis, etc.), history of head radiation therapy, cancerous or precancerous lesions, etc; (3) Have received permanent (such as polymethyl methacrylate) or semi permanent fillers (such as hydroxyapatite calcium, polylactic acid, etc.), autologous fat, etc. under the orbit or around the eyes within 24 months prior to screening, or planned to receive such treatment during clinical trials; (4) Temporary fillers such as cross-linked hyaluronic acid or collagen injection therapy have been used under the orbit within 12 months, or non cross-linked hyaluronic acid or collagen injection has been received under the orbit within 3 months before enrollment; (5) Screening for individuals who may be affected by cosmetic surgery or cosmetic procedures in the suborbital injection area or around the eyes within the first 6 months or during the study period, such as facial elevation, botulinum toxin injection, laser, radio frequency, etc., that may affect the evaluation of depression efficacy; (6) Those with scars or tattoos under the orbit that affect visual evaluation; (7) Individuals with a history of allergies to local anesthetics such as sodium hyaluronate or lidocaine, as well as a history of severe allergic reactions; (8) Patients with platelet count below 50 × 109/L or abnormal coagulation mechanism (APTT time extension>10s or PT time extension>3s) during the screening period, or those who have received anticoagulant, antiplatelet, or thrombolytic therapy (such as warfarin, aspirin, etc.) within two weeks; (9) Abnormal liver and kidney function during the screening period (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 and lupus erythematosus; (10) Screening for those who have received chemotherapy, immunosuppressive agents, immunomodulatory therapy (such as monoclonal antibodies), or systemic corticosteroids (excluding inhaled corticosteroids) within the first three months; (11) Long term use of phenobarbital ß Receptor blockers and drugs that can interact with lidocaine; (12) Pregnant, lactating women, or those planning to conceive during the study period; (13) Individuals who have participated in other intervention clinical trials within the month prior to this trial; (14) Researchers believe that other individuals are not suitable for participating in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of improving suborbital depression 3 months after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Analyzing the volume change of the suborbital depression area (left and right sides added) compared to baseline through 3D digital imaging;Blind researcher suborbital depression scale score;Injection Researcher's Suborbital Depression Scale Score;Assessment of Global Cosmetic Efficacy (GAIS) by Injection Researchers;Subject's rating of global cosmetic effect (GAIS);Digital Rating Scale (NRS) scoring; | — |
Countries
China
Contacts
Public ContactWu Wenyu
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed