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

Study Identifier
M21-500
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, German, Hungarian, Polish

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
  • Study Drug
  • Placebo
  • 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. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study was to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in participants with moderate to severe GL.

    This was a 12-week study in which eligible subjects were enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants were randomly assigned to receive AGN-151586 or placebo. There was 1 in a 4 chance that participants would receive placebo. Around 600 adult participants with moderate to severe GL were to be enrolled in the study in approximately 38 sites across the world.

    Participants received either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may have received an open-label treatment of AGN-151586 during the study.

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

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Derm Ctr /ID# 232378
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Clinical Testing of Beverly Hills /ID# 233195
    Encino, California, United States, 91436-2124
    Status
    Not applicable
    Location
    Westside Aesthetics /ID# 232443
    Los Angeles, California, United States, 90025-1708
    Status
    Not applicable
    Location
    The Research Center at The Maas Clinic /ID# 241262
    San Francisco, California, United States, 94115-1809
    Status
    Not applicable
    Location
    Center for Dermatology and Dermatologic Surgery /ID# 232315
    Washington D.C., District of Columbia, United States, 20037-1445
    Status
    Not applicable
    Location
    Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232439
    Boca Raton, Florida, United States, 33431-6465
    Status
    Not applicable
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