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A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines
Sponsor: AbbVie
Summary
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 product being developed for the treatment of GL. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. One group will receive AGN-151586 followed by BOTOX and the other group will receive placebo followed by BOTOX. There is a 1 in 2 chance that participants will be assigned to placebo. Around 80 adult participants with moderate to severe GL will be enrolled in the study in approximately 10 sites around the United States. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive BOTOX injections on Day 30 and will be followed for up to 4 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Official title: A Phase 1 Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) in Subjects for Treatment of Glabellar Lines
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2022-08-30
Completion Date
2023-05-30
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
AGN-151586
Intramuscular Injection
BOTOX
Intramuscular Injection
Placebo
Intramuscular Injection
Locations (10)
The Eye Research Foundation /ID# 244430
Newport Beach, California, United States
Cosmetic Laser Dermatology /ID# 244425
San Diego, California, United States
AboutSkin Research, LLC /ID# 244416
Greenwood Village, Colorado, United States
Skin Research Institute LLC /ID# 244424
Coral Gables, Florida, United States
Skin and Cancer Associates, LLP /ID# 244415
Miami, Florida, United States
DeNova Research /ID# 244421
Chicago, Illinois, United States
Advanced Dermatology /ID# 244427
Lincolnshire, Illinois, United States
Laser and Skin Surgery Center of Indiana /ID# 244423
Indianapolis, Indiana, United States
Bellaire Dermatology Associates /ID# 244428
Bellaire, Texas, United States
Premier Clinical Research /ID# 244429
Spokane, Washington, United States