Temple hollowing
Conditions
Interventions
Treatment:Injection research products
Control:Injection research products
Sponsors
The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: subjects must be at least 18 years old when signing ICF. 2. Gender: male and female. 3. Subject type and temporal depression characteristics (1) Subjects seeking to improve temporal depression. (2) In EI field evaluation, subjects with mild, moderate or severe temporal depression on each side (grade 2, 3 or 4 on aths) (both sides of the temporal must meet the requirements, but not need to have the same score). 4. Informed consent (1) Subjects who are able to sign an informed consent form, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. (2) Written informed consent of the subjects was obtained prior to any study related process. (3) Written documents have been obtained (where applicable) in accordance with the relevant national and local privacy requirements. 5. Others (1) Subjects assessed by Ti to be able and willing to follow the study instructions (including compliance with the Safety log) and may complete all required study visits. (2) Subjects who were able to complete the effectiveness self-assessment without using glasses (if all subjects could wear contact lenses in their self-assessment, they were accepted to wear contact lenses).
Exclusion criteria
Exclusion criteria: 1. Medical conditions (1) Ti believed that after the subjects received the permitted injection dose, the temporal improvement of both sides could not reach at least one level compared with the baseline aths score assessed by the evaluation researchers. (2) Temporal depression due to trauma, congenital malformation or congenital or acquired dyslipidemia. Others include congenital myotonic dystrophy, HIV related dyslipidemia or acquired systemic dyslipidemia. (3) There were temporal trauma, residual defect, deformity or scar formation within 6 months before admission. (4) Temporal skin atrophy that Ti thought might not be suitable for injection. (5) Current or previous history of temporal arteritis. (6) Temporomandibular joint dysfunction or any other mandibular problem. (7) Recurrent temporal headache, such as temporal tendinitis, migraine. (8) There is a tendency to form hypertrophic scar. (9) Active autoimmune diseases. (10) Allergic reactions or history of allergic reactions to lidocaine (or any amide based anesthetic), ha products or streptococcal proteins. (11) there are skin inflammation and infectious diseases (such as acne, herpes), abscesses, wounds, canceration or precancerous lesions above the nasal region. 2. Past / concomitant treatment (1) Previous history of facial reconstruction, facial lift or eyebrow lift, and temporal surgery (e.g., biopsy). (2) History of temporal fat injection or permanent facial implant implantation (e.g. polymethylmethacrylate, silica gel, polytetrafluoroethylene). (3) Except for the temporal part, the history of fat injection or permanent facial implant implantation (such as polymethylmethacrylate, silica gel, polytetrafluoroethylene) in any part of the face within 12 months before enrollment. (4) Treatment history of semi permanent soft tissue fillings (such as calcium hydroxyapatite, poly-L-lactic acid) in the temporal or midfacial region within 36 months before enrollment. (5) History of temporary skin filling injection in the area above the inferior nasal point within 12 months before enrollment. (6) In the first 3 months, there was a history of temporary skin filling injection in the nasolabial sulcus or the area below the inferior nasal point. (7) History of botulinum toxin treatment in the area above the inferior nasal point or masseter muscle within 6 months before enrollment. (8) Plastic therapy or facial cosmetic surgery, such as laser, light conditioning therapy, intense pulsed light, radio frequency, skin grinding, chemical exfoliation of medium or greater depth or other exfoliative treatment. (9) Wearing braces or other orthodontic treatment, or planning to carry out such treatment during the study, or planning to change the over-the-counter or over-the-counter oral or topical anti wrinkle products in the area above the infranasal point during the study within 30 days before enrollment. (10) If the subjects start using any new over-the-counter or over-the-counter oral or topical anti wrinkle products in the area above the infranasal point within 30 days before enrollment, they will not meet the requirements of this study. Subjects who had used these products at least 30 days before enrollment and intended to continue using them throughout the study were eligible to participate in the study. (11) Receiving anticoagulant therapy (such as warfarin, clopidogrel). 3. Previous / current clinical research experience Currently participating in research drug or device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ATHS; | — |
Countries
China
Contacts
Public ContactJiaming Sun
Union Hospital Affiliated to Tongji Hospital of Huazhong University of science and technology
Outcome results
None listed