temporal depression
Conditions
Interventions
Test group:Injection filling with cross-linked sodium hyaluronate gel containing hydroxyapatite microspheres for medical use
Control group:None
Sponsors
Medical Ethics Committee of West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old (including 18 years old), gender is not limited; 2. Subjects who are willing to improve temporal depression; 3. According to the evaluation of the blinded evaluation investigator and the treating investigator, the subject has mild to severe depression in both temporal regions (i.e., bilateral ATHS score is 2-4 points, and the same score is not required but the difference between the two sides is <=1 point; 4. Voluntarily sign a written informed consent form, understand and accept the duration of the study, and be able and willing to comply with all requirements, including treatment, follow-up, and other study procedures as planned.
Exclusion criteria
Exclusion criteria: 1. Individuals who are known to be allergic to hyaluronic acid products, hydroxyapatite calcium, or any component in the investigational medical device; Or those with a known history of severe allergic reactions or any history of anaphylactic shock; 2. Individuals with abnormal coagulation mechanisms during the screening period (activated partial thromboplastin time (APTT)>1.5 times the upper limit of normal), or those who have received any thrombolytic, anticoagulant, or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks prior to screening; 3. Temporal depression caused by trauma, congenital malformation, or congenital or acquired lipodystrophy; 4. Patients with the following conditions in the temporal region: (1) Previous or current temporal arteritis; (2) Temporal trauma or tissue defects, deformities, or scars caused by trauma in the temporal region; (3)Temporal skin atrophy that may not be suitable for injection; (4) Temporomandibular joint dysfunction or any other jaw problems; (5)Recurrent temporal headaches, such as temporal tendinitis, migraine, etc; 5. Tattoos, punctures, obvious facial hair, scars, deformities, unhealed wounds, active skin diseases or inflammations or infections (such as herpes, acne, eczema, dermatitis, psoriasis, shingles, etc.), abscesses, granulomas, cancerous or precancerous lesions that may affect efficacy evaluation or increase treatment risk in the area above the nasal tip; 6. Patients who have undergone or plan to undergo upper facial reconstruction, facial lift, and temporal region surgery during previous trials (such as biopsy, mid upper facial reconstruction, maxillofacial fracture surgery, etc.); 7. Patients who have undergone or plan to undergo comprehensive surgical procedures during previous trials (such as autologous fat transplantation, absorbable implant thread therapy, wrinkle removal surgery, etc.); 8. Those who have received or plan to receive any permanent filler treatment in the temporal region during the trial period (such as polymethyl methacrylate, organosilicon, expanded polytetrafluoroethylene, etc.); 9. Patients who have received or plan to receive treatments such as hydroxyapatite calcium, poly (L-lactic acid), poly (lactic acid), poly (bisoprolol), poly (caprolactone), etc. within the 24 months prior to temporal screening; 10. Individuals who have received or plan to receive injection therapy of cross-linked sodium hyaluronate or other unknown materials within the past 12 months prior to screening in the area above the nasal tip; 11. Individuals who have undergone or plan to undergo any cosmetic treatment or facial surgery (such as non crosslinked sodium hyaluronate treatment (excluding "water light injection"), collagen injection, botulinum toxin treatment, radiofrequency treatment, ultrasound treatment, laser, moderate or deeper chemical peels, skin abrasions, or other ablation surgeries) within the 6 months prior to screening in the area above the nasal point; 12.Individuals who have received or plan to receive water light injection or photon therapy within the past 3 months prior to screening in the area above the nasal tip; 13. Individuals with active autoimmune diseases or a medical history (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.); 14.Individuals who have received chemotherapy, immunosuppressive therapy, immunomodulatory therapy (such as monoclonal antibodies), or systemic corticosteroid treatment (e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate of temporal depression improvement at 6 months after the last injection in the experimental group/after randomization in the control group (as evaluated by blinded evaluators); | — |
Secondary
| Measure | Time frame |
|---|---|
| Equipment defect incidence rate (%) and number of incidents;Local reaction rate (%) and number of events at the injection site;vital signs;Laboratory Examination;Efficacy rate of temporal depression improvement (as evaluated by blinded evaluators, excluding the assessment time points of the primary efficacy endpoint);Effective rate of improving temporal depression (evaluated by treatment researchers);Overall aesthetic improvement effect evaluation (treatment researcher and subject evaluation);Changes in temporal volume compared to baseline;Subject satisfaction and recommendation evaluation;Incidence rate (%) and number of (serious) adverse events;Incidence rate (%) and number of device related (serious) adverse events; | — |
Countries
China
Contacts
Public ContactGuo Li
Medical Ethics Committee of West China Hospital of Stomatology, Sichuan University
Outcome results
None listed