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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 - AGN-151586 and BOTOX 		Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14.
  • Drug: AGN-151586
    Injection
  • Drug: BOTOX
    Injection
Experimental
Cohort 2 - AGN-151586 and BOTOX 		Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21.
  • Drug: AGN-151586
    Injection
  • Drug: BOTOX
    Injection

Recruiting Locations

Advanced Research Associates - Glendale /ID# 283833
Glendale, Arizona 85308

Eye Research Foundation /ID# 283835
Newport Beach, California 92663

Pacific Clinical Innovations /ID# 283812
Vista, California 92083

Etre, Cosmetic Dermatology And Laser Center /ID# 283831
New Orleans, Louisiana 70130

Skincare Physicians /ID# 283851
Chestnut Hill, Massachusetts 02467

Wilmington Dermatology Center /ID# 283853
Wilmington, North Carolina 28403

Tennessee Clinical Research Center /ID# 283894
Nashville, Tennessee 37215

Austin Institute for Clinical Research - Pflugerville /ID# 283817
Pflugerville, Texas 78660

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.