A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for I… (NCT06499688) | Clinical Trial Compass
CompletedPhase 3
A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
China529 participantsStarted 2023-12-28
Plain-language summary
This is a randomized, double-blind, placebo- and active-controlled parallel-group multi-center phase III study to evaluate the efficacy and safety of Rcombinant botulinum neurotoxin type A for injection (YY001)) in the treatment of moderate to severe glabellar lines.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form.
✓. At screening and baseline, moderate to severe glabellar lines (grade of 2 or 3 on the 4-point Scale) at maximal frown as assessed by both the Investigator and the participant on-site.
✓. Agree to participate in the study and sign the informed consent form.
✓. At the discretion of the investigator, the participants can comply with the protocol requirements.
✓. Females and/or males of childbearing potential and their partners: those who should be using effective contraception and have no plans for childbearing, egg donation (females), or sperm donation (males) from the signing of the informed consent form to 3 months after the last administration. Female participants of childbearing potential must have had a negative blood pregnancy test (human chorionic gonadotropin) within 7 days prior to the administration of study drug or a urine pregnancy test examination must be negative 3 days prior to the administration of study drug.
✓. Women of childbearing potential are those who have experienced menarche, have not undergone sterilization (hysterectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation), and are not in a state of post-menopausal (defined as absence of menstrual bleeding for 12 months prior to screening, without any other medical reason).
✕. Known allergy to any component of the test product (includes investigational product and comparator product), or hypersensitivity.
What they're measuring
1
The 4th week after treatment, the composite response rate on both the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown.
Timeframe: The 4th week after treatment
2
At the 1st week, 8th week, and 12th week after treatment, the composite response rate on both the investigator's assessment and the participant's self- assessment concurrently of GL severity at maximal frown.
Timeframe: At the 1st week, 8th week, and 12th week after treatment
✕. Previous cosmetic manipulation of the area between the eyebrows, within 12 months prior to screening; implantation of autologous fat or any permanent material; history of upper face lifting or semi-permanent prosthetic fillers, etc.; or plan to undergo upper face cosmetic manipulation during the study period (note: except for study drug injections);
✕. Use of any botulinum toxin within 6 months prior to baseline, or planned use of botulinum toxin during the study (note: except for use of investigational drugs at the study site).
✕. Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants (e.g., heparin, coumarins, non-vitamin K antagonists, oral anticoagulants within 1 week prior to baseline.
✕. Use of medications that affect neuromuscular transmission within 4 weeks prior to baseline, including but not limited to: muscarinic agents, aminoglycosides, anticholinergic agents, benzodiazepines.
✕. At screening and baseline, skin abnormalities at the injection site
✕. Inability to substantially lessen glabellar lines by physically spreading them apart, as determined by the investigator.
✕. Ptosis, significant facial asymmetry, excessive skin laxity at screening or baseline, or a history of any of the above.