Temporal depression
Conditions
Interventions
Experimental group:Polycaprolactone Microspheres for Injection Recombinant Type III Humanized Collagen-Sodium Hyaluronate Lyophilized Fiber Combination Pack
Control group:None
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years old (including 18 years old and 65 years old), male or female; (2) Subjects who are willing to undergo recombinant type III humanized collagen-sodium hyaluronate lyophilized fiber combination package for injectable polycaprolactone microspheres for temporal filler therapy; (3) As evaluated by the blinded investigator, the subject has a flat to severe temporal depression on both sides (i.e., the bilateral ATHS score is 2-4 points, and the same score is not required but the bilateral difference shall not exceed 2 points); (4) Voluntarily sign the informed consent form, understand and accept the duration of the study, and be able and willing to comply with all study requirements, including treatment, follow-up and other study procedures as planned, and be able to cooperate with clinical follow-up and diary card filling.
Exclusion criteria
Exclusion criteria: (1) Those who are known to be allergic to polycaprolactone (PCL) or any ingredient in this product; (2) Subjects with a known history of severe allergic reactions and multiple severe allergies; (3) Those who have participated in clinical trials of other drugs or medical devices in the last 3 months and have not been out of the group; (4) Patients with open wounds or active skin infections at the injection site; (5) Patients with abnormal coagulation mechanism (activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal) during the screening period, or have received any thrombolytic, anticoagulant or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks prior to enrollment; (6) Temporal depression caused by trauma, congenital malformation, or congenital or acquired lipodystrophy; (7) Past or present temporal arteritis; (8) Temporomandibular joint dysfunction or other jaw diseases; (9) Recurrent temporal headache, such as temporal tendonitis, migraine, etc.; (10) Subjects who have received any permanent or semi-permanent fillers in the temporal part (such as calcium hydroxyapatite, poly-L-lactic acid, polymethyl methacrylate, silicone, expanded PTFE, polycaprolactone, autologous fat, etc.); (11) Those who have received cross-linked sodium hyaluronate injection above the subnasal point and other unknown material injections (except for nasolabial fold and mid-facial treatment) within 12 months prior to enrollment(12) Those who have undergone face lift (thread lift) above the subnasal point within 12 months before enrollment; (13) Collagen injection therapy, radiofrequency therapy, botulinum toxin injection, such as periorbital wrinkle removal, treatment of masseter muscle hypertrophy, etc. (except for nasolabial fold and mid-facial treatment) above the subnasal point within 6 months prior to enrollment; (14) Patients who have received non-cross-linked sodium hyaluronate injection therapy (including skin boosters), ultrasound therapy, laser or chemical peeling, dermabrasion, etc. above the subnasal point within 3 months prior to enrollment; (15) Presence of facial conditions that may affect the evaluation of efficacy or increase the risk of treatment (such as: tattoos, piercings, obvious facial hair (such as beards, etc.), prone to pigmentation, scarring, deformities, unhealed wounds, active skin diseases, etc.); (16) Those who have received chemotherapy, immunosuppressants, immunomodulatory therapies (such as monoclonal antibodies, etc.) or systemic corticosteroids (except inhaled corticosteroids) within 3 months prior to enrollment; (17) 1 year prior to enrollment or ongoing or planned to undergo various operations or surgical treatments affecting the upper facial contour such as orthodontics, dental implants, installation of dentures, etc., during the study period; (18) Those who have undergone surgery on the temporal region, which is judged by the investigator to affect the evaluation of efficacy; (19) Subjects with active autoimmune diseases or history (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.), active sepsis, porphyria, etc.: (20) As judged by the investigator, with malignant tumors or severe insufficiency of vital organs (such as brain, heart, lung, liver, kidney, etc.): such as severe cardiovascular and cerebrovascular diseases, severe lung diseases, liver function: ALT or AST> 2 times the upper limit of normal, renal function: serum creatinine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate of temporal depression improvement (Evaluated by blinded evaluators); | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy rate of improvement from baseline in temporal depression at 1, 3, 6, 9 months after the last injection (Evaluated by blinded evaluators);Efficacy rate of improvement in temporal depression within 12 months after the last injection compared to baseline period (Evaluated by injection researchers);Improvement rate of Global Aesthetic Outcome Scale (GAIS) within 12 months after the last injection compared to baseline period (evaluated by injection researchers and subjects);Changes in subject satisfaction within 12 months after the last injection compared to the baseline period (evaluated by the subjects); | — |
Countries
China
Contacts
Public ContactWang Hang
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed