A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines

Study Identifier
M23-365
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
  • BOTOX
  • Placebo
  • Phase
    Phase 1
    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 assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL.

    AGN-151586 is an investigational product being developed for the treatment of GL. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. One group will receive AGN-151586 followed by BOTOX and the other group will receive placebo followed by BOTOX. There is a 1 in 2 chance that participants will be assigned to placebo. Around 80 adult participants with moderate to severe GL will be enrolled in the study in approximately 10 sites around the United States.

    Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive BOTOX injections on Day 30 and will be followed for up to 4 months.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    The Eye Research Foundation /ID# 244430
    Newport Beach, California, United States, 92663-3637
    Status
    Not applicable
    Location
    Cosmetic Laser Dermatology /ID# 244425
    San Diego, California, United States, 92121-2119
    Status
    Not applicable
    Location
    AboutSkin Research, LLC /ID# 244416
    Greenwood Village, Colorado, United States, 80111
    Status
    Not applicable
    Location
    Skin Research Institute LLC /ID# 244424
    Coral Gables, Florida, United States, 33146-1837
    Status
    Not applicable
    Location
    Skin and Cancer Associates, LLP /ID# 244415
    Miami, Florida, United States, 33137-3254
    Status
    Not applicable
    Location
    DeNova Research /ID# 244421
    Chicago, Illinois, United States, 60611
    Status
    Not applicable
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