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Also known as Botulinum toxin type A purified neurotoxin complex
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 involving visible bands or cords in the neck. The program is in Phase 2 clinical development. It is an investigational use and has not been established as a treatment for this indication.
BOTOX purified neurotoxin complex is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the company responsible for the clinical development program in platysma prominence.
BOTOX purified neurotoxin complex is in Phase 2 development for platysma prominence. One Phase 2 trial has been completed, and no trials for this indication are currently active. The asset remains investigational for this use.
The Phase 2 trial NCT03915067, titled BOTOX for the Treatment of Platysma Prominence, evaluated BOTOX purified neurotoxin complex in adults with platysma prominence. It enrolled 171 participants across the United States and Canada, was randomized, double blind, and placebo controlled, and has been completed.
Yes. BOTOX purified neurotoxin complex is also written as BOTOX purified neurotoxin complex with the registered trademark symbol. Both names refer to the same AbbVie product and development program, so searches using either name point to the same asset.
The Phase 2 trial NCT03915067 enrolled 171 participants. It accepted adults aged 18 years and older of any sex and did not enroll healthy volunteers. The study was randomized, double blind, and placebo controlled, and it has been completed.