A Phase 1 interventional study of AGN-151586 and BOTOX in Glabellar Lines, sponsored by AbbVie. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
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Exclusion Criteria:
Presence or history of any medical condition that may place the participant at increased risk following exposure to AGN-151586 or BOTOX interfere with the study evaluation, including:
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months.
Drug: AGN-151586 · Drug: BOTOX
Participants will receive 5 intramuscular injections of placebo in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months.
Drug: BOTOX · Drug: Placebo
Intramuscular Injection
Intramuscular Injection
Also known as: OnabotulinumtoxinA
Intramuscular Injection
Percentage of Participants achieving "none" or "mild" on the Facial Wrinkle Scale (FWS) according to the investigator assessment of Glabellar Lines (GL) severity at maximum frown
The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
Time frame: At Day 60
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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