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New Frown-Line treatment shows promise in large trial

NCT ID NCT05248880

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new botulinum toxin, AGN-151586, for treating moderate to severe frown lines between the eyebrows. About 300 adults who had never received any botulinum toxin treatment were randomly assigned to get either the study drug or a placebo. The main goal was to see if the treatment safely reduced frown lines at maximum frown after one week, as judged by both doctors and participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

309 people

The number who actually took part.

Started

Mar 2022

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable). * Participant must have 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. * Participants must not have a history of any use of botulinum neurotoxin of any serotype for any indication (including any investigational botulinum neurotoxin product). * Presence or history of any medical condition that may place the participant at increased risk following exposure to AGN-151586 or 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 known immunization to any botulinum neurotoxin serotype. * Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed. * 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. * Female subject who is pregnant or breastfeeding, and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer. * Participant who has been treated with any investigational drug within 30 days of the drug prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study. * Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glabellar lines

Contacts and locations

Locations

  • Clear Dermatology & Aesthetics Center /ID# 238990

    Scottsdale, Arizona, 85255-4134, United States

  • Clinical Research Center of the Carolinas /ID# 239064

    Charleston, South Carolina, 29407, United States

  • Clinique D /ID# 239653

    Laval, Quebec, H7N 6L2, Canada

  • DMR Research PLLC /ID# 239061

    Westport, Connecticut, 06880, United States

  • DelRicht Research /ID# 244890

    Baton Rouge, Louisiana, 70809, United States

  • Dr Melinda Gooderham Medicine Profession /ID# 239657

    Cobourg, Ontario, K9A 0Z4, Canada

  • Duplicate_Austin Institute for Clinical Research /ID# 238989

    Pflugerville, Texas, 78660, United States

  • Duplicate_Kavali Plastic Surgery and Skin Renewal Center /ID# 244808

    Atlanta, Georgia, 30328, United States

  • Kalo Clinical Research /ID# 247279

    West Valley City, Utah, 84120-2058, United States

  • Marcus Medical Spa /ID# 241703

    Redondo Beach, California, 90277, United States

  • Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067

    Hunt Valley, Maryland, 21030-3216, United States

  • Pacific Derm /ID# 239654

    Vancouver, British Columbia, V6H 4E1, Canada

  • SkinDC /ID# 238988

    Arlington, Virginia, 22209, United States

  • Steve Yoelin MD Medical Associate Inc /ID# 243197

    Newport Beach, California, 92663, United States

  • The Centre for Clinical Trials /ID# 245873

    Oakville, Ontario, L6J 7W5, Canada

  • WDC Cosmetic and Research, PLLC /ID# 233935

    Wilmington, North Carolina, 28405, United States

  • YVR Aesthetics Training & Study Centre /ID# 241858

    Vancouver, British Columbia, V5Z 1H2, Canada

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