Moderate to severe brow lines
Conditions
Interventions
Phase I 10u test group:In this experiment, a single dose was administered in the glabellar region, including five injection sites: one injection site in the middle of the glabellar depressor muscle, o
Phase I 10u placebo group:In this experiment, a single dose was administered in the glabellar region, including five injection sites: one injection site in the middle of the glabellar depressor muscle
Phase II trial drug low dose group:In this experiment, a single dose was administered in the glabellar region, including five injection sites: one injection site in the middle of the glabellar depress
Phase II trial drug high dose group:In this experiment, a single dose was administered in the glabellar region, including five injection sites: one injection site in the middle of the glabellar depres
Phase II positive control group:In this experiment, a single dose was administered in the glabellar region, including five injection sites: one injection si
Sponsors
Chinese Academy of Medical Sciences Plastic Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. the age at the time of signing the informed consent was 18-65 years old (including the boundary value), and there was no limit on gender; 2. the severity of the brow lines at the time of the maximum frown of the subjects assessed by the researchers and subjects using the facial wrinkle scale (FWS) met the moderate and severe criteria (according to the 4-point FWS scale score of 2 or 3); 3. the subjects can understand the requirements of the clinical trial, follow the research protocol and visit plan, voluntarily participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. subjects with a history of severe multiple allergies or allergies leading to anaphylactic shock, or previous allergic reactions to any type of botulinum toxin or other components of the test drug; 2. the facial region had been treated with botulinum neurotoxin (BoNT) of any serotype within 6 months before screening; The 3. those who have received medical and aesthetic treatment other than botulinum toxin in the glabellar area (including the forehead) within 12 months before screening, and have been judged by the investigator to affect the effectiveness and safety of this study, including but not limited to: any biodegradable filler implantation, microneedles, deep laser treatment, deep chemical stripping, scar removal surgery, skin grinding, pulling and catgut embedding, etc; Or plan to receive the above facial cosmetic procedures during the study; 4. patients who received medical and aesthetic treatment other than botulinum toxin in the glabellar area (including the forehead) within 1 month before screening, and who were judged by the investigator to affect the effectiveness and safety of this study, including but not limited to: shallow laser freckle removal, Photorejuvenation, water light needle, shallow chemical peeling, eyebrow embroidery, etc; Or plan to receive the above facial cosmetic procedures during the study; The 5. have received previous treatment for the glabellar area (including forehead), such as rhytidectomy, permanent filling (non biodegradable, such as silica gel, polyacrylamide, etc.) or semi permanent filling (such as hydroxyapatite, polylevolactic acid or polymethylmethacrylate, etc.) or autologous fat filling, or there is scar in this area that affects the treatment result; 6. having received botulinum toxin facial wrinkle removal in the past with poor effect (including the treatment effect of eyebrow wrinkles) or serious adverse reactions, the investigator judged that it was not suitable to participate in this study; 7. having a past history of serious respiratory, circulatory, digestive, urinary, blood, endocrine and metabolic, immune, nervous system and other major diseases, the investigator judged that it was not suitable to participate in this study; The 8. suffer from any neurological disease in which exposure to botulinum toxin type a increases the risk, including peripheral motor nerve diseases (such as amyotrophic lateral sclerosis and motor neuropathy) and neuromuscular junction diseases (such as Lambert Eaton syndrome and myasthenia gravis); 9. there is active skin infection or inflammation at the injection site, or there is systemic skin disease that may affect the effectiveness or safety evaluation of the brow lines; 10. in the relaxed state, the investigator judged that the wrinkle appearance of the treatment area could not be significantly improved by physical expansion, or the investigator used the facial wrinkle scale (FWS) to assess the subjects' brow line severity score > 1 point during static relaxation; 11. the face is obviously asymmetric, the eyelids / eyebrows are obviously drooping, the skin is excessively loose, and the dermal scar is serious; 12. sebaceous gland skin in the upper third of the face is too thick or muscular hypertrophy; 13. there is muscle weakness or muscle atrophy at the treatment site, or there is a history of facial nerve paralysis; 14. use of drugs affecting neuromuscular conduction effect within 4 weeks before screening, including but not limited to: muscle relax
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AES), incidence and severity of serious adverse events (SAEs), assessment of injection site related adverse events, and dose limiting toxicity (DLT) assessment.;The response rate of the investigator to the on-site assessment of the severity of the brow line at the time of maximum frowning: the investigator assessed the proportion of the subjects whose severity of the brow line at the time of maximum frowning improved by at least 2 points from the baseline through ila-fws.;The response rate of the investigator to the on-site assessment of the severity of the brow line at the time of maximum frown: the investigator assessed the proportion of the severity of the brow line at the time of maximum frown improved by at least 2 points from the baseline through ila-fws.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The composite response rate of the investigator and the subject on-site to assess the severity of the brow line at the time of maximum frowning: the proportion that the severity of the brow line at the time of maximum frowning improved by at least 2 points from the baseline as assessed by the investigator on-site through the facial wrinkle scale (ila-fws) and the subject on-site through the facial wrinkle scale (pfws);;The proportion of subjects who improved the severity of brow lines by at least 2 points from baseline at the time of maximum frowning through pfws self-assessment;; The proportion of subjects who improved the severity of brow lines by at least 1 point from baseline during relaxation through pfws self-assessment;;The investigator assessed the proportion of subjects who had at least 2 points improvement from baseline in the severity of brow lines at the time of maximum frowning through ila-fws;;The investigator assessed the proportion of subjects whose brow line severity improved by at least 1 point from baseline during relaxation through ila-fws;;The subjects' overall aesthetic improvement self-assessment (GAis) was the proportion of effect improvement (effect improvement was defined as GAis score >= +2 (moderate improvement));;Evaluation of subject satisfaction rate (the score range of the subject satisfaction scale is 7, from 1 (very dissatisfied) to 7 (very satisfied). Satisfaction was defined as: a score >= 6 (satisfied) was regarded as the subject's satisfaction).;Proportion of positive anti drug antibody;Subjects assessed the proportion of subjects who had at least 2 points improvement from baseline in the severity of brow lines at the time of maximum frowning through pfws;;The composite response rate of the investigator and the subject to the on-site assessment of the severity of the brow line at the time of maximum frowning: the proportion of subjects who met the ila-fws assessment and pfws assessment that the severity of the brow line at the t | — |
Countries
China
Contacts
Public ContactWang Baoxi
Chinese Academy of Medical Sciences Plastic Surgery Hospital
Outcome results
None listed