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

Study Identifier
M21-508
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
  • Study Drug
  • AGN-151586
  • Placebo
  • 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 is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in toxin-naïve participants with moderate to severe GL.

    This is a 12 week study in which eligible subjects will be enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 300 adult participants with moderate to severe GL will be enrolled in the study in approximately 15 sites.

    Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive an open-label treatment of AGN-151586 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
    Clear Dermatology & Aesthetics Center /ID# 238990
    Scottsdale, Arizona, United States, 85255-4134
    Status
    Not applicable
    Location
    Steve Yoelin MD Medical Associate Inc /ID# 243197
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Marcus Medical Spa /ID# 241703
    Redondo Beach, California, United States, 90277
    Status
    Not applicable
    Location
    DMR Research PLLC /ID# 239061
    Westport, Connecticut, United States, 06880
    Status
    Not applicable
    Location
    Duplicate_Kavali Plastic Surgery and Skin Renewal Center /ID# 244808
    Atlanta, Georgia, United States, 30328
    Status
    Not applicable
    Location
    DelRicht Research /ID# 244890
    Baton Rouge, Louisiana, United States, 70809
    Status
    Not applicable
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