A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)

Last updated: May 5, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Placebo

OnabotulinumtoxinA

AGN-151586

Clinical Study ID

NCT06834789
M25-207
  • Ages > 18
  • All Genders

Study Summary

The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both theinvestigator and participant using the Facial Wrinkle Scale (FWS).

  • Must be in good health as per investigator's judgment based on medical history,physical examination, vital sign measurements, 12-lead ECG parameters, clinicallaboratory evaluations, and neurological assessment.

Exclusion

Exclusion Criteria:

  • Active infection or dermatological condition at the treatment injection sites.

  • History of immunization to any botulinum neurotoxin serotype or hypersensitivity toany botulinum neurotoxin serotype or any other constituents of the study drug or itsexcipients, and/or other products in the same class.

Study Design

Total Participants: 126
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1
Study Start date:
February 18, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Investigate MD /ID# 270771

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Eye Research Foundation /ID# 270827

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Marcus Facial Plastic Surgery /ID# 270770

    Redondo Beach, California 90277
    United States

    Active - Recruiting

  • Skin Research Institute LLC /ID# 270831

    Coral Gables, Florida 33146-1837
    United States

    Active - Recruiting

  • Skincare Physicians /ID# 271018

    Chestnut Hill, Massachusetts 02467
    United States

    Active - Recruiting

  • Wilmington Dermatology Center /ID# 270828

    Wilmington, North Carolina 28403
    United States

    Active - Recruiting

  • Austin Institute for Clinical Research - Pflugerville /ID# 270834

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • SkinDC /ID# 270932

    Arlington, Virginia 22209
    United States

    Active - Recruiting

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