A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

Study Identifier
M21-509
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
  • Study Drug
  • AGN-151586
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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 evaluate the safety of AGN-151586 over multiple repeat treatments of the study drug to improve the appearance of glabellar lines.

    AGN-151586 is an investigational product being developed for the treatment of GL. Around 940 to 1100 adult participants with moderate to severe GL will be enrolled in the study in approximately 45 sites in the United States.

    This is an open-label, 126 day study in which all participants will receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive up to 2 additional cycles of treatment during the study.

    Participants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

    Study Locations

    Location
    Status
    Location
    Skin Wellness Dermatology - Homewood /ID# 241233
    Birmingham, Alabama, United States, 35209-8314
    Status
    Not applicable
    Location
    Advanced Research Associates - Glendale /ID# 232245
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Skin Care and Laser Physicians of Beverly Hills /ID# 241237
    Los Angeles, California, United States, 90069
    Status
    Not applicable
    Location
    The Eye Research Foundation /ID# 232229
    Newport Beach, California, United States, 92663-3637
    Status
    Not applicable
    Location
    Cosmetic Laser Dermatology /ID# 243513
    San Diego, California, United States, 92121-2119
    Status
    Not applicable
    Location
    UC San Diego Health - University Center Lane - La Jolla /ID# 241243
    San Diego, California, United States, 92122-1013
    Status
    Not applicable
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