Combination of two botulinum toxins for upper facial lines in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, interventional trial examines the safety and efficacy of a single treatment using a co-reconstituted mix of trenibotulinumtoxinE and onabotulinumtoxinA for adults with moderate to severe glabellar and upper facial lines. It has two parts, with Part 1 focusing on glabellar lines. Participants are randomized to receive the toxin combination, onabotulinumtoxinA alone, or placebo, to compare outcomes. Eligibility requires measurable glabellar line severity, good overall health, and no contraindicating conditions. Exclusion criteria include severe resting glabellar lines and prior botulinum toxin immunization.

Why it matters

Who can join: the full rules

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

Where it's running

• Total Skin and Beauty Dermatology Center /ID# 284360
  Birmingham, Alabama, United States Recruiting
• Advanced Research Associates - Glendale /ID# 284389
  Glendale, Arizona, United States Recruiting
• Eye Research Foundation /ID# 284401
  Newport Beach, California, United States Recruiting
• Pacific Clinical Innovations /ID# 284406
  Vista, California, United States Recruiting
• DMR Research - Westport /ID# 286612
  Westport, Connecticut, United States Recruiting
• Sherber+Rad /ID# 286392
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Head-to-Head Comparison of BoNT-A Treatments for Glabellar Lines

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.