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Completed

NCT Number: NCT05496335

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Eye Research Foundation /ID# 244430, Newport Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable).
  • Participants with moderate or severe Glabellar Lines at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at screening and baseline (Day 1) visit.

Exclusion criteria

  • Uncontrolled systemic disease.
  • 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:
  • Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
  • History of facial nerve palsy
  • Infection or dermatological condition at the treatment injection sites
  • Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart
  • Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator
  • History of clinically significant drug, nicotine, or alcohol abuse within the last 6 months.
  • Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
  • History of known immunization to any botulinum neurotoxin serotype.
  • Anticipated need for surgery or overnight hospitalization during the study.
  • History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
  • History of periorbital, mid-facial, or upper-facial treatment with semi permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
  • Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or participants with a positive polymerase chain reaction (PCR) test in the past 14 days prior to Baseline Day 1 who are asymptomatic.
  • Participant who has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.

Treatment and study plan

AGN-151586

Drug

Intramuscular Injection

Botox

Drug

Intramuscular Injection

Other names: OnabotulinumtoxinA

Placebo

Drug

Intramuscular Injection

Primary outcomes

  1. 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

    Time frame: At Day 60

    The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) in Subjects for Treatment of Glabellar Lines

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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