Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BOTOX purified neurotoxin complex · 1 trial · 1 indication
The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| BOTOX® Low Dose | EXPERIMENTAL | Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| BOTOX® High Dose | ACTIVE_COMPARATOR | Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| Name | Type | Description |
|---|---|---|
| BOTOX® purified neurotoxin complex | DRUG | BOTOX® superficial intramuscular injections. |
| Placebo | DRUG | Placebo injections. |
Inclusion Criteria: * Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period * A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breas...
BOTOX purified neurotoxin complex is being studied for the treatment of Platysma Prominence, a condition characterized by prominent bands in the neck. It is currently in Phase 2 clinical development as an investigational therapy for this indication.
BOTOX purified neurotoxin complex is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research to evaluate this product for Platysma Prominence.
BOTOX purified neurotoxin complex is in Phase 2 clinical development for Platysma Prominence. It is an investigational product and has not been approved for this use. One Phase 2 trial has been completed to evaluate its safety and efficacy.
BOTOX purified neurotoxin complex has one completed Phase 2 clinical trial, NCT03915067, titled "BOTOX® for the Treatment of Platysma Prominence." This randomized, double-blind, placebo-controlled study enrolled 171 participants in the United States and Canada.
BOTOX purified neurotoxin complex is a specific formulation of botulinum toxin type A being studied for Platysma Prominence. It is related to the BOTOX brand but is under investigation for this particular indication, distinct from other approved uses of BOTOX.