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CompletedNCT05496335Updated Jun 26, 2026

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

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

From the registry’s dates

  • Primary completion was May 2023, 3 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glabellar Lines

Keywords

  • AGN-151586
  • OnabotulinumtoxinA
  • BOTOX
03

In context

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    AGN-151586, BOTOX

    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

  • Experimental
    Placebo, 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

Interventions

  • DrugAGN-151586

    Intramuscular Injection

  • DrugBOTOX

    Intramuscular Injection

    Also known as: OnabotulinumtoxinA

  • DrugPlacebo

    Intramuscular Injection

06

What researchers measure

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

    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

07

Study locations

10 sites
  • The Eye Research Foundation /ID# 244430
    Newport Beach, California 92663-3637, United States
  • Cosmetic Laser Dermatology /ID# 244425
    San Diego, California 92121-2119, United States
  • AboutSkin Research, LLC /ID# 244416
    Greenwood Village, Colorado 80111, United States
  • Skin Research Institute LLC /ID# 244424
    Coral Gables, Florida 33146-1837, United States
  • Skin and Cancer Associates, LLP /ID# 244415
    Miami, Florida 33137-3254, United States
  • DeNova Research /ID# 244421
    Chicago, Illinois 60611, United States
  • Advanced Dermatology /ID# 244427
    Lincolnshire, Illinois 60069, United States
  • Laser and Skin Surgery Center of Indiana /ID# 244423
    Indianapolis, Indiana 46260-2386, United States
  • Bellaire Dermatology Associates /ID# 244428
    Bellaire, Texas 77401, United States
  • Premier Clinical Research /ID# 244429
    Spokane, Washington 99202, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05496335
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Aug 11, 2022
Start date
Aug 30, 2022
Primary completion
May 30, 2023
Completion
May 30, 2023
Last update
Jun 26, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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