Moderate to severe eyebrow creases
Conditions
Interventions
Test group:Surgical tool: facial injection surgery navigation positioning system
control group:Surgical tool: traditional manual injection
Sponsors
Plastic Surgery Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Male or female participants aged 18 to 65 years old; (2) Subjects were rated for the severity of their eyebrow creases using Facial Wrinkle Scale (FWS) when frowning as much as possible, with a rating of = 2 (moderate or severe); (3) Individuals who have not been injected with botulinum toxin (any serotype) in any part of the face for at least 6 months (excluding); (4) The subjects have good compliance, can fully understand the clinical trial, have reasonable expectations for the cosmetic effects of injection, and can follow the research procedures until the clinical trial is completed; (5) Subjects who voluntarily sign informed consent forms.
Exclusion criteria
Exclusion criteria: (1) Subjects who have previously experienced allergic reactions to botulinum toxin (any serotype) or other components of the investigational drug; (2) Suffering from any neurological disorders that increase the risk of exposure to botulinum toxin type A, including peripheral motor nerve diseases (such as amyotrophic lateral sclerosis and motor neuropathy), as well as neuromuscular junction diseases (such as Lambert Eaton syndrome and myasthenia gravis); (3) Using botulinum toxin (any serotype) for immunotherapy, expected to require botulinum toxin treatment (any serotype) during the trial period, or having a history of botulinum toxin poisoning; (4) Expected treatment with botulinum toxin on the face or other parts during the study period; (5) There is muscle weakness or atrophy in the treated area, or a history of facial nerve paralysis (such as Bell paralysis); (6) Skin diseases, active infections, or inflammation at the injection site; (7) There is obvious asymmetry in the face, drooping eyelids or medical history, obvious drooping eyebrows or medical history, excessive skin laxity, deep dermal scars, and thick sebaceous skin; (8) The eyebrow creases of the subjects cannot be fully unfolded through surgery or finger smoothing; (9) Any classification of the House Brackmann facial nerve function grading should score 2 or above; (10) Previously received surgical treatment for the eyebrow area (including forehead) (such as facial lift surgery or semi permanent prosthesis filling history), or implanted autologous fat or any permanent materials (such as silicone oil, polyacrylamide, etc.) in the eyebrow area (including forehead), regardless of the time interval between previous treatment and this study; (11) Within the first 30 days of screening or during the study period, use of steroid drugs (such as hydrocortisone and triamcinolone acetonide) at the treatment site that may interfere with the evaluation of the treatment site; (12) Screening for the use of retinoic acid drugs at the treatment site within the first three months or during the expected study period, or other drugs or cosmetics that the researcher determines may affect the efficacy evaluation of the treatment site; (13) During screening, 12-lead electrocardiogram (ECG) abnormalities met the following criteria: QTcF interval>450 ms (male) or>450 ms (female), 2nd or 3rd degree atrioventricular block, PR interval>220 ms, atrial fibrillation, ventricular tachycardia, QRS wave duration>119 ms. QTcF=QT/(RR ^ 0.33), where RR is the standardized heart rate divided by 60 divided by heart rate. (14) Suffering from hyperkalemia or medical history, hypokalemia or medical history, torsade de pointe (TdP), unstable angina, myocardial infarction, congestive heart failure, or having a family history of QT prolongation (long QT syndrome); (15) Hypertensive patients whose blood pressure has not been effectively controlled (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg), except for those who have been effectively controlled through antihypertensive drug treatment; (16) Antibiotics that may affect neuromuscular junction function, such as aminoglycoside antibiotics (such as gentamicin and neomycin), peptide antibiotics (such as polymyxin B), tetracyclines, and lincomycin, are expected to be used within 3 days before or after treatment, but do not include topical antibiotics; (17) Use of neuromuscular blocking drugs (such as arrow venom) during the study period; (18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiencies in treating frowned eyebrows as much as possible; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment effectiveness in a relaxed state;Facial wrinkle status questionnaire (FLO-11 scale);Facial wrinkle treatment satisfaction questionnaire (FTS scale);Self Age Perception Scale (SPA Scale);Visual Analog Evaluation System (VAS Score); | — |
Countries
China
Contacts
Public ContactYongqian Wang
Plastic Surgery Hospital of Chinese Academy of Medical Sciences
Outcome results
None listed