Temporal depression
Conditions
Interventions
Experimental group:Use experimental medical equipment for 2 injections+2 supplementary injections
Control group:No treatment, follow-up only
Sponsors
West China Stomatological Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range of 18 to 65 years old (including 18 and 65 years old), gender is not limited; 2. Willing to improve patients with temporal depression; 3. Blind researchers evaluated the subjects' bilateral temporal ATHS scoring scale (Allergan Temple Hollowing) Scale and ATHS ratings are both between 2 and 4 levels, with a difference of no more than 1 level between the two sides; 4. According to the assessment of the treatment researcher, there are no significant visual impairments; 5. Participants voluntarily participate in clinical trials and sign informed consent forms; Capable and willing to comply with the researcher's Guide, follow the medication and treatment restrictions specified in this protocol, and complete all visits of this trial as required regard
Exclusion criteria
Exclusion criteria: 1. Study participants are blind or partially blind in both eyes; Previous severe and uncontrolled eye disease (e.g., glaucoma, cataract, optic neuritis, fundus lesions); 2. Severe allergy to a variety of allergens, or allergy to the components of drugs or devices used in the test process (such as amide anesthetics such as lidocaine, poly-L-lactic acid, sodium carboxymethylcellulose, mannitol, etc.); 3. Presence of any disease or lesion near or within the area to be treated, such as: inflammation, active or chronic infection (such as oral, head and neck areas); facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex or shingles; scarring or deformity; cancer or precancerous lesions (e.g., smooth keratoses); 4. Those who have conditions in the relevant temporal area that will interfere with visual assessment, such as tattoos, piercings, hair; 5. Underwent or planned to undergo the following surgeries or treatments during the study period that may affect the evaluation of the safety and effectiveness of the investigational device: a) Planned prior to screening or during the study: fat injections in the temporal region, implantation of permanent facial fillers (e.g., polymethyl methacrylate, silicone, or PTFE) or non-absorbable wires; b) 3 months prior to screening or planned during the study period: use of photomodulation therapy, intense pulsed light, superficial ablation or other ablative treatments in the temporal region (such as AHAs at concentrations below 10% or salicylic acids at concentrations below 2%, etc.); c) Planned facial injection of botulinum toxin 6 months prior to screening or during the study; Temporal area (except frontal area) treated with mesotherapy, laser, radiofrequency, ultrasound and other energy devices (except photomodulation therapy and intense pulsed light), dermabrasion, chemical peels of medium or greater depth, or other ablative treatments (such as trichloroacetic acid, carbolic acid, 10% or more concentration of fruit acids or 2% or more concentration of salicylic acid, etc.); d) 12 months before screening or planned during the study period: rejuvenation surgery in the temporal region (such as endoscopic facial wrinkle (lifting), open face wrinkle removal, short scar wrinkle removal, small incision facial suspension lift, internal and external canthoplasty, eyelid margin incision blepharoplasty, eye bag plastic surgery and midface lift, etc.); Injection of degradable skin fillers (such as hyaluronic acid, collagen, etc.) in the temporal area or implantation of absorbable filaments; e) 24 months prior to screening or planned during the study period: semi-permanent dermal filler treatment in the temporal region (such as calcium hydroxyapatite, poly-L-lactic acid, etc.); 6. Patients with temporal depression due to trauma, congenital malformations (such as congenital myotonic dystrophy), congenital or acquired malnutrition (such as HIV-related lipodystrophy); 7. Patients with temporal skin atrophy who may not be suitable for injection; 8. Those who have temporal arteritis or have a history of temporal arteritis in the past; 9. Patients with recurrent temporal pain, such as migraine, temporal tendonitis, cluster headache; 10. History of malignant tumor or history of chemoradiotherapy; 11. Those who have temporomandibular joint and oral problems that are not suitable for inclusion after being examined by the investigator, or who have undergone oral surgery within 6 months before screening o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ATHS correction efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Scale, GAIS; | — |
Countries
China
Contacts
Public ContactWang Hang
West China Stomatological Hospital of Sichuan University
Outcome results
None listed