Temporal depression
Conditions
Interventions
Experimental group:Use a poly-l-l-lactic acid filler for injection
Control group:don't do any temporal therapy
Sponsors
West China Stomatological Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects are over 18 years old, regardless of gender. 2. Subjects are willing to undergo temporal filling therapy. 3. The subjects have mild, moderate or severe temporal depression (grade 2, grade 3 or grade 4 in evaluation by blind researchers) and the difference in the score of bilateral temporal should not be more than grade 1. 4. The subject is in good compliance, willing to follow the study instructions, follow the medication and treatment restrictions specified in this protocol, and complete all study visits as required. 5. Subjects fully understand the purpose and design of the clinical study and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The subject is blind or partially blind in both eyes; Past glaucoma, retinal detachment, macular degeneration, optic neuritis and other uncontrollable eye diseases. 2. A history of severe or multiple allergies to any component of the product (e.g., poly-l-lactic acid, mannitol, or sodium carboxymethyl cellulose) or to local anesthetics (e.g., lidocaine or other amide anesthetics). 3. Patients who have a history of bleeding or are currently on treatment regimens for other diseases containing drugs known to prolong clotting time (e.g., warfarin) are unwilling or unable to stop using these drugs within 2 weeks prior to screening. 4. Subjects with prior depression or ongoing antidepressant treatment. 5. Temporal depression due to trauma, congenital malformations (e.g., congenital myotonic dystrophy), or congenital or acquired lipodystrophy (e.g., HIV-related lipodystrophy). 6. The subjects have active autoimmune diseases, such as systemic lupus erythematosus. 7. The subject has the following diseases or lesions in the middle and upper parts of the face to be treated: a) inflammatory, active or chronic infection; b) vitiligo, psoriasis, psoriasis, eczema, acne, etc.; c) scar or deformity; d) Cancer or precancerous lesions (e.g., actinic keratosis). 8. The subject has atrophy of the temporal skin that may not be suitable for injection; There are tattoos, piercings, facial hair, or scars in the temporal region that may interfere with visual evaluation. 9. Subject has a current or past history of temporal arteritis. 10. The subjects have joint diseases such as temporomandibular joint dysfunction. 11. Subjects have recurrent temporal headache, such as temporal tendinitis and migraine. 12. Have previously had cosmetic surgical injections, facial lifts and surgeries, or plan to have cosmetic surgical injections, facial lifts and surgeries during the trial, meeting any of the following points: a) Previous history of upper facial reconstruction, facial lift, and temporal region surgery (e.g., mid-upper facial reconstruction Surgery, maxillofacial fracture, etc.); b) A history of permanent fillings in the temporal region (e.g., autologous fat transplantation, silicone prosthesis fillings) Filled, PTFE filled, polyethylene PMMA); c) A history of semi-permanent soft-tissue fillings in the temporal region within 24 months prior to enrollment (e.g Lactic acid, polycaprolactone, facial lift embedding, etc.); d) A history of temporary absorbable dermal fillers injected in the temporal region within 12 months prior to enrollment (e.g., Hyaluronic acid, collagen, etc); e) History of facial botulinum toxin treatment or orthodontic treatment within 6 months prior to enrollment; f) Facial cosmetic surgery (e.g., skin grinding, medium depth or greater depth) within 3 months prior to enrollment Chemical exfoliation or other exfoliative treatment); g) Plan to undergo other cosmetic facial treatment or dental surgery, tooth extraction or at any time during the study period Dental implant; Wear braces or other orthodontic treatment, or plan to have such treatment during the study period. 13. The following abnormalities occurred in hematology and clinical biochemistry, which were not effectively corrected before enrollment: a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were greater than 2 times the upper limit of normal value (ULN) (refer to the laboratory of the research center to check the normal value range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ATHS scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| GAIS scale; | — |
Countries
China
Contacts
Public ContactWang Hang
West China Stomatological Hospital, Sichuan University
Outcome results
None listed