TrenibotulinumtoxinE and OnabotulinumtoxinA for Upper Facial Lines
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Recruiting
Phase 2Interventional Study
Upper Facial LinesGlabellar Lines
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for adults with moderate to severe upper facial lines. Participants will receive a single treatment with a combination of two botulinum toxins.
Are You a Good Fit for This Trial?
You may be able to join if
I have moderate or severe glabellar lines.
I am in good health according to my doctor.
I do not have any conditions that may significantly interfere with my participation.
You may not be able to join if
I have severe glabellar lines at rest.
I have a history of allergic reactions to botulinum toxins.
I have an active infection or skin condition at the injection site.
I have been diagnosed with myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
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