The objective of this Phase 2 study is to assess the safety and efficacy of single treatment of trenibotulinumtoxinE and onabotulibumtoxinA combination in adult participants with moderate to severe upper facial lines. The study has two parts; Part 1 evaluates treatment for glabellar lines.
For glabellar lines (GL) indication: participant must have moderate or severe GL at maximum furrow as assessed by both the investigator and participant using the AGLSS at Screening and Baseline (Day 1) visits.
Participant must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead electrocardiogram (ECG) parameters, clinical laboratory evaluations, and neurological assessment.
In the investigator's opinion, participant must not have a condition or be in a situation that may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
For GL Indication: Severe GL at rest as assessed by the investigator using the AGLSS at Screening or Baseline (Day 1).
History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients
Active infection or dermatological condition at the treatment injection sites.
Medical condition that may put the subject at increased medical risk with exposure to botulinum toxin, including diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
Parallel
TrenibotulinumtoxinE and OnabotulinumtoxinA
DrugInjection
Placebo
DrugInjection
OnabotulinumtoxinA
DrugInjection
10
Treatment groupsSee each treatment group below.
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Percentage of Participants Achieving None or Mild on the Investigator-Assessed Allergan Glabellar Lines Severity Scale (AGLSS)
Achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity.
Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS
Achievement of None or Mild on the subject-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity.
Duration Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
Duration AUC (area under the curve) for time-averaged response based on achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe). This endpoint measures the duration of treatment effect over time.
Onset Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS
Onset AUC (area under the curve) for time-averaged response based on achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe). This endpoint measures the rapidity of onset of treatment effect.
