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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07756580

Registry updated: 2026-09-09
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Description

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, participants in Cohort 1 will receive intramuscular injections of BOTOX on Day 14, and participants in Cohort 2 will receive intramuscular injections of BOTOX on Day 21. Participants will be followed for up to approximately 141 days.

Interventions

  • AGN-151586 (Drug)
    Injection
  • BOTOX (Drug)
    Injection

Eligibility criteria

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

Conditions

Glabellar Lines

Locations

  • Advanced Research Associates - Glendale /ID# 283833 — Glendale, Arizona, United States
  • Eye Research Foundation /ID# 283835 — Newport Beach, California, United States
  • Pacific Clinical Innovations /ID# 283812 — Vista, California, United States
  • Etre, Cosmetic Dermatology And Laser Center /ID# 283831 — New Orleans, Louisiana, United States
  • Skincare Physicians /ID# 283851 — Chestnut Hill, Massachusetts, United States
  • Wilmington Dermatology Center /ID# 283853 — Wilmington, North Carolina, United States
  • Tennessee Clinical Research Center /ID# 283894 — Nashville, Tennessee, United States
  • Austin Institute for Clinical Research - Pflugerville /ID# 283817 — Pflugerville, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record