Moderate to severe eyebrow lines
Conditions
Interventions
Positive control group:Botulinum toxin type A for injection ( Baotuoshi )
Medium dose test group:Inject medium dose recombinant botulinum toxin type A (Sf9 cells, 150 kD natural amino acid sequence)
Low-dose test group:Injection of low-dose recombinant botulinum toxin type A (Sf9 cells, 150 kD natural amino acid sequence)
The placebo group:Recombinant botulinum toxin type A ( Sf9 cells, 150 kD natural amino acid sequence ) placebo for injection
high-dose test group:Injection of high-dose recombinant botulinum toxin type A (Sf9 cells, 150 kD natural amino acid sequence)
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adult males or females aged 18-65 years old ( including the boundary value ) at the time of signing the informed consent form; 2. Screening and baseline, at the same time meet : based on the researcher 's on-site assessment of the severity of eyebrow wrinkles at the maximum frown, the degree of eyebrow wrinkles is moderate and severe ( IGA-FWS scale score is 2 or 3 ) based on the on-site assessment of the severity of eyebrow striae at the maximum frowning, the degree of eyebrow striae was moderate and severe ( PFWS scale score was 2 or 3 ). 3. Agreeing to participate in clinical trials and voluntarily signing informed consent; 4. Male subjects and fertile female subjects were willing to take effective contraceptive measures throughout the study period ( effective contraceptive measures include : vasectomy, abstinence, intrauterine contraceptive device, hormone [ oral, patch, ring, injection, implantation ], barrier method [ diaphragm, cervical cap, sponge, condom ] ) the pregnancy test of female subjects with fertility must be negative male subjects were not allowed to donate sperm within 3 months after the study drug administration.
Exclusion criteria
Exclusion criteria: 1. having a history of allergies to any component of the research drug ( including the test drug and the control drug ), or having a history of hypersensitivity reactions; 2. Previously received cosmetic procedures in the interbrow area ( including the forehead area ), such as dermal filling ( cross-linked hyaluronic acid was filled in the skin within 12 months before screening receive non-crosslinked water-light needles within 6 months before screening patients received intense pulsed light, microneedle, chemical exfoliation or scar removal surgery, skin grinding within 3 months before screening. Biodegradable fillers with non-hyaluronic acid as the main component of skin filling in the first 2 years were screened, such as collagen, polylactic acid and hydroxyapatite calcium. Implantation of autologous fat or any permanent material [ such as silicone oil, polyacrylamide, etc., no matter how long the interval ], upper face ( between the infraorbital margin and the hairline ) lifting surgery ( such as eyelid plasty, eyebrow lifting, etc. ) or semi-permanent prosthesis filling history within 5 years before screening or plan to receive facial cosmetic procedures ( except for drug injection ) during the study period, such as facial lifting, skin filling, prosthesis implantation, photoelectric therapy, hydro-optical needle, micro-needle, chemical peeling or scar removal surgery, skin grinding, etc. 3. Botulinum toxin was injected within 6 months before screening, or botulinum toxin was planned to be used during the study period ( except for the use of research drugs at the study site ); 4. Previously received botulinum toxin facial wrinkle removal effect is not good or serious adverse reactions, the researchers judged not suitable to participate in this study; 5. Use non-steroidal anti-inflammatory drugs or anticoagulants including aspirin within 1 week before baseline ( such as heparin, coumarins, non-vitamin K antagonists, oral anticoagulants [ such as imixaban, dabigatran, edoxaban, rivaroxaban, etc. ] ); 6. In the first 4 weeks of screening, the drugs affecting neuromuscular conduction were used, including but not limited to : muscle relaxants ( such as dantrolene chloride, dantrolene sodium, baclofen, etc. ), aminoglycosides ( such as gentamicin, streptomycin, spectinomycin hydrochloride, etc. ), anticholinergic drugs ( such as atropine, scopolamine, bromobutane, benzhexol hydrochloride, etc. ), benzodiazepines ( such as chlordiazepine, diazepam, triazolam, chlordiazepine, etc. ); 7. Screening of patients who had used topical drugs ( such as glucocorticoids, tretinoin ointment ) on the upper face ( between the infraorbital margin and the hairline ) within the previous 4 weeks, or who were expected to use these drugs on the upper face during the study; 8. Subjects may be required to accept the prohibited drugs specified in the study protocol during the study period, as assessed by the researcher; 9. Screening and baseline, injection site skin abnormalities ( such as treatment area infection, such as acne, herpes simplex, etc. ) and in the advanced stage, skin diseases ( psoriasis, eczema, etc. ) in the advanced stage, scar ( such as deep dermal scar, etc. ) or scar constitution, or with other skin problems, the researchers judged that may affect the effectiveness and safety evaluation of eyebrow lines; 10. Based on the researcher 's judgment, eyebrow lines cannot be fully developed by surgery or finger caressing; 11. Ptosis, obvious f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of clinically significant abnormal changes such as laboratory tests ( including blood routine, blood biochemistry, urine routine, etc. ), 12-lead electrocardiogram, vital signs, and physical examination, etc. during the research period.;The incidence of adverse events and serious adverse events during the study period ; the incidence of injection site reaction ;; | — |
Secondary
| Measure | Time frame |
|---|---|
| The response rate of the improvement of eyebrow lines obtained by the field assessment of the severity of eyebrow lines without frowning on the 7th, 14 th and 28 th day after treatment was evaluated.;The satisfaction rate of the subjects on the 7 th, 14 th and 28 th day;The production of anti-drug antibodies and neutralizing antibodies on the 14 th and 28 th day after treatment.;On the 7th, 14 th and 28 th day after treatment, the response rate of the improvement of eyebrow lines obtained by the on-site assessment of the severity of eyebrow lines at the maximum frown time;The response rate of eyebrow wrinkle improvement obtained by the field assessment of the severity of eyebrow wrinkles at the maximum frowning time was evaluated.;Response rate of eyebrow wrinkle improvement obtained from on-site evaluation of the severity of eyebrow wrinkles when not frowning by researchers;The improvement rate of the subjects ' self-assessment of the severity of the brow lines at the maximum frowning time;the improvement rate of the severity of eyebrow wrinkles at the maximum frown time was evaluated by the researchers.; | — |
Countries
China
Contacts
Public ContactYan Wu
Peking University First Hospital
Outcome results
None listed