Suborbital depression
Conditions
Interventions
Experimental group:The suspension of polyl-lactic acid in combination with sodium hyaluronate was utilized for injection.
Control group:Don't do anything to the infraorbital area
Sponsors
West China Stomatological Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 to 65 years (inclusive), no gender restrictions. 2. Aim to improve bilateral infraorbital depression. 3. As evaluated by a blinded assessor, both sides of the bilateral infraorbital depression were classified as AIHS grade 2-3 (moderate to severe) (it is not necessary for the evaluation results of the left and right sides to be equal, but the difference between them should not exceed grade 1). 4. Researchers determined that there were no significant abnormalities in visual function. 5. Participants are required to provide voluntary informed consent prior to participating in the experiment.
Exclusion criteria
Exclusion criteria: 1. current or previous uncontrolled retinal disease (e.g., retinal detachment) or any other disease that may cause vision loss (e.g., uncontrolled diabetes), disease that causes increased eye pressure (e.g., glaucoma), hemifacial spasm, exophthalmia (e.g., hyperthyroidism); 2. Have a history of severe or multiple allergies to any component of the test product (e.g., poly-L-lactic acid, mannitol, sodium carboxymethyl cellulose or sodium hyaluronate) or to local anesthetics (e.g., lidocaine or other amide anesthetics); 3. Trauma in the area to be treated or defects or deformities in the periorbital or cheek area within 6 months before enrollment; 4. Previous history of midfacial (nasofrontal NFA to subnasal septum) surgery, cosmetic surgical treatment, or plan to undergo cosmetic surgical treatment during the trial, meeting any of the following points: a) Have had surgery in the lower eyelid area, including suborbital and mid-face surgery. b) has ever received a permanent facial implant (e.g., polymethyl methacrylate, silicone, teflon) or plans to have any of these products implanted during the study period; c) A history of treatment with semi-permanent soft tissue fillers (e.g., poly-l-lactic acid, calcium hydroxyapatite, etc.) within 24 months prior to enrollment; Or plan to implant such products during the study; d) A history of temporary absorbable skin fillers (e.g., hyaluronic acid, collagen, etc.) injected within 12 months prior to enrollment; Or plan to implant such products during the study; e) Facial history of botulinum toxin treatment within 6 months before enrollment; f) There was a history of radiofrequency, optoelectronic, beauty plastic, and chemical Q10 treatment on the face within 3 months before enrollment; 5. Local skin infections (including viral, bacterial, fungal, etc.) or any other skin diseases (such as keloids, local papules, nodules, skin granulomas) in the area to be treated; Active or progressive or homomorphic skin diseases such as acute eczema, warts plana, lichen planus, psoriasis vulgaris, or malignant tumors or skin masses of unknown nature; There are unknown injection substances in the area to be treated; 6. Tattoos, deformities, unhealed wounds, piercings, facial hair (such as beards, mustaches), etc. in the area to be treated, which may affect the evaluation of efficacy; 7. Cicatricial constitution; 8. Present with immune system disease, or may require immunosuppressive drugs during the trial (e.g., severe, uncontrolled asthma, rheumatoid arthritis, autoimmune disease, etc.); 9. Suffering from coagulation dysfunction or other systemic diseases; The presence of coagulation dysfunction (APTT APTT > 1.5 times the upper limit of normal laboratory value, which the investigators determined to be clinically significant) or the use of anticoagulant drugs, such as warfarin, which the investigators determined to increase the risk of bleeding at the implant site; 10. Have serious heart, liver and kidney diseases; Uncontrolled diabetes; 11. Those undergoing chemotherapy/radiotherapy; 12. Patients with mental illness or emotional instability; The presence of central nervous system disorders and mental disorders that may adversely affect this clinical trial and cannot be fully understood and co-operated; 13. Pregnant and lactating women and those with a family plan during the trial; 14. The expectation of treatment effect is too high; 15. There are other general circumstances that are not suitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement of infraorbital depression was effective; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement of infraorbital depression was effective;Overall beauty effect improves efficiency;Subjects self-rated the overall beauty effect improvement efficiency; | — |
Countries
China
Contacts
Public ContactWang Hang
West China Stomatological Hospital, Sichuan University
Outcome results
None listed