Temple hollowing
Conditions
Interventions
Treatment group:Crosslinked sodium hyaluronate gel for injection
Control group:N/A
Sponsors
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be at least 18 years old, whose gender can be male or female; 2) Subjects with mild, moderate or severe temporal depression on each side (grade 2, 3 or 4 on the Temple Hollowing Scale) determined by Evaluating Investigators of institution hospitals and seeking for correction; 3) Volunteered to participate in the study, able to sign the informed consent, fully understand the content, process and possible adverse reactions of trial, and agree to participate in all visits, examinations and treatments as required by protocol; 4) Able to complete the effectiveness self-assessment without wearing spectacles.
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant, lactating, during puerperium or planning to conceive in the following year; 2) Had severe mental disorders, psychological disorders, personality disorders or taking antipsychotic drugs; 3) Had a history of serious diseases in vital organs (cardiovascular system, pulmonary, hepatic, renal and nerve system, etc.); 4) Had diabetes, autoimmune diseases or abnormal coagulation function; 5) Had systematic or treatment-site infection; 6) Treating Investigators believed that after the subjects received injection, the temporal improvement of both sides could not reach at least one level compared with the baseline score assessed by the Evaluating Investigators; 7) Temporal depression due to trauma, congenital malformation or congenital or acquired dyslipidemia, such as congenital myotonic dystrophy, HIV related dyslipidemia or acquired systemic dyslipidemia; 8) Tempus with following situations: Temporal trauma or trauma induced residual defect, deformity or scar formation; Temporal skin atrophy not suitable for injection; Temporomandibular joint dysfunction or any other mandibular problem; Recurrent temporal headache, such as temporal tendinitis, migraine; 9) There are active skin diseases, wounds, canceration or precancerous lesions above the inferior nasal point; 10) There is a tendency to form hypertrophic scar or keloid; 11) Allergic to hyaluronic acid or any other components involved in this study; 12) Past treatment: Previous history of facial reconstruction, facial lift, eyebrow lift or temporal surgery (e.g., biopsy); History of temporal fat injection or permanent facial implant implantation (e.g. polymethylmethacrylate, silica gel, polytetrafluoroethylene); 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; History of temporary skin filling injection in the area above the inferior nasal point within 12 months before enrollment; Except for the temporal part, the history of fat injection or permanent facial implant implantation in any part of the face within 12 months before enrollment; History of temporary skin filling injection in the nasolabial sulcus or the area below the inferior nasal point within 6 months before enrollment; History of botulinum toxin treatment in the area above the inferior nasal point or masseter muscle within 6 months before enrollment; Mesotherapy or facial cosmetic surgery, such as laser, radio frequency, skin grinding, chemical exfoliation of medium or greater depth or other exfoliative treatment within 6 months before enrollment; 13) Had thrombolysis, anticoagulation, antiplatelet therapy or hormone therapy within 2 weeks before or after injection; 14) Facial hair or scars that may interfere with the visual evaluation of the temporal region located above the inferior nasal point; 15) Significant weight changes (more than 10% of body weight) were planned during the study period; 16) Participating in such clinical trial within 30 days of participating in this research; 17) Any situation estimated as unsuitable for the trial by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Temple Hollowing Scale; | — |
Countries
China
Contacts
Public ContactSun Jiaming
Outcome results
None listed