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)

Study Identifier
M25-207
CT.gov Identifier
NCT06834789
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • AGN-151586
  • OnabotulinumtoxinA
  • Placebo
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator 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, clinical laboratory evaluations, and neurological assessment.
    Exclusion Criteria:
    * Active infection or dermatological condition at the treatment injection sites. * History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.

    Protocol 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).

    Study Locations

    Location
    Status
    Location
    Investigate MD /ID# 270771
    Scottsdale, Arizona, United States, 85260
    Status
    Not applicable
    Location
    Eye Research Foundation /ID# 270827
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Marcus Facial Plastic Surgery /ID# 270770
    Redondo Beach, California, United States, 90277
    Status
    Not applicable
    Location
    Skin Research Institute LLC /ID# 270831
    Coral Gables, Florida, United States, 33146-1837
    Status
    Not applicable
    Location
    Skincare Physicians /ID# 271018
    Chestnut Hill, Massachusetts, United States, 02467
    Status
    Not applicable
    Location
    Wilmington Dermatology Center /ID# 270828
    Wilmington, North Carolina, United States, 28403
    Status
    Not applicable
    Showing {first} - {last} of {total} Results