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A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines

RecruitingPhase 1Ages 18 Years - anyAllAbbVie
NCT07756580 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL. AGN-151586 is an investigational drug being developed for treatment of moderate to severe glabellar lines. Participants are placed into 1 of 2 groups called treatment arms. In both arms participants will receive both AGN-151586 and BOTOX. Approximately 120 adult participants with moderate to severe glabellar lines enrolled in the study in approximately 8 sites around the United States. Participants will receive injections of AGN-151586 on Day 1 in the glabellar complex. After meeting treatment criteria, particip

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📋 Eligibility rules (as published)
Inclusion Criteria: * Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline (Day 1) Visits * Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, and 12-lead ECG parameters * Must have sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their GL, in the opinion of the investigator. Exclusion Criteria: * Severe glabellar lines at rest as assessed by the investigator using the FWS * Prior exposure to botulinum neurotoxin of any serotype within the last 12 months prior to screening * History of hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug
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What it tests

  • AGN-151586
  • BOTOX
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Where

8 sites
Advanced Research Associates - Glendale /ID# 283833
Glendale, United States
Eye Research Foundation /ID# 283835
Newport Beach, United States
Pacific Clinical Innovations /ID# 283812
Vista, United States
Etre, Cosmetic Dermatology And Laser Center /ID# 283831
New Orleans, United States
Skincare Physicians /ID# 283851
Chestnut Hill, United States
Wilmington Dermatology Center /ID# 283853
Wilmington, United States
Tennessee Clinical Research Center /ID# 283894
Nashville, United States
Austin Institute for Clinical Research - Pflugerville /ID# 283817
Pflugerville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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