crow's feet
Conditions
Interventions
Experimental group: Treating crow's feet in subjects with botulinum toxin using needle-free injection technology
Control group:Injecting botulinum toxin for crow's feet treatment using a regular insulin injection needle.
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Chinese males or females aged between 18 and 65. 2. According to the investigator's assessment, moderate to severe crow's feet were present at maximum smile. 3. According to the subject's assessment, moderate to severe crow's feet were present at maximum smile. 4. Women who are not potentially fertile or women of childbearing potential with a negative urine pregnancy test at screening and baseline, and agree to use highly effective and approved methods of contraception during the study period. 5. Have the time and ability to complete the study and adhere to the guidelines. 4. Women of non-fertile potential or women of childbearing age who have a negative urine pregnancy test at screening and baseline and agree to use highly effective and approved contraceptive methods during the study. 5. Have the time and ability to complete research and follow instructions.
Exclusion criteria
Exclusion criteria: 1. Use any botulinum toxin in the facial area within 36 weeks before the study. 2. During the study period, for any reason, it is expected to receive treatment with any serotype of botulinum toxin (excluding the study product). 3. Women who are pregnant, breastfeeding, or plan to become pregnant during the study. 4. Known allergy to botulinum toxin or a history of hypersensitivity reactions. 5. GL that cannot be significantly improved by physical stretching, as determined by the investigator. 6. Abnormal laboratory test results at screening with significant clinical implications, or abnormal targeted physical examination findings at screening or baseline visit, as judged by the investigator. 7. Excessive skin relaxation in the treatment area or around the eyes. 8. Any hyaluronic acid soft tissue filler treatment in the glabellar or forehead region within 24 weeks prior to baseline. 9. History of use of any permanent (non-biodegradable, such as silicone, polyacrylamide, etc.) or semi-permanent (i.e., calcium hydroxyapatite, polylactic-co-glycolic acid, or polymethyl methacrylate) products, suspension threads, or autologous fat for soft tissue augmentation in the treatment area. 10. History, current status, or trend of ptosis of the eyelids or eyebrows, poor visual acuity, or previous periorbital surgery that may lead to such events, as judged by the investigator. 11. Significant facial asymmetry, excessive skin relaxation (i.e., accumulation of eyelid skin), or pronounced asymmetry around the eyes or eyebrows. 12. Scarring, piercings, or tattoos (including eyebrow or eyeliner tattoos) in the treatment area or surrounding areas that might interfere with study evaluation, as judged by the investigator. 13. Inflammation, active infection, or skin diseases such as eczema, rosacea, facial psoriasis, shingles, etc., in the treatment area or nearby. 14. Cancer or precancerous lesions in the treatment area. 15. Other facial treatments, surgeries, or cosmetic procedures (such as ablative skin resurfacing, laser therapy, microneedling, chemical peels) within 48 weeks before enrollment that could potentially interfere with study injections and/or evaluations, as judged by the investigator. 16. Plans to undergo facial surgery, ocular surgery (including LASIK), or facial cosmetic procedures (such as ablative skin resurfacing, laser therapy, microneedling, chemical peels, botulinum toxin therapy, or dermal fillers) during the study period. 17. Current facial nerve palsy or a history of related conditions, or any medical disease that may increase the risk of exposure to botulinum toxin for the participant, including confirmed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that may affect neuromuscular function. 18. Use of medications that affect neuromuscular transmission, such as depolarizing muscle relaxants like succinylcholine, lincomycin derivatives, polymyxin, anticholinesterases, and aminoglycoside antibiotics. 19. Participants with bleeding disorders or currently using anticoagulants. 20. Participants with a past or present history of psychiatric disorders (such as psychosis, depression, anxiety), alcohol abuse or substance misuse, or are taking antidepressants, anxiolytics, or antipsychotics considered by the investigator to potentially affect participant safety and/or participation in the study. 21. Other concomitant medical conditions, treatments, or ci
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GAIS score; | — |
Countries
China
Contacts
Public Contactzhongyang sun
Beijing Hospital
Outcome results
None listed