Facial Wrinkles
Facial Wrinkles
M21-500 Enrolling

Glabellar (Frown) Lines Research Trial (14 Weeks)

Treatment: Injection Age: 18 Years

Adults at least 18 years old with moderate or severe Glabellar Lines (GL) at maximum frown, assessed by using the Facial Wrinkle Scale (FWS), may qualify for this clinical research trial. These wrinkles between the eyebrows are ones that develop from repeated facial expression. Qualified individuals must not have received treatment with any botulinum neurotoxin for aesthetic treatment within the last 6 months, and for therapeutic treatment within the last 12 months.

Participants will receive investigational medication (active study drug) or placebo via injection. Study medication and study-related care will be provided at no cost to you. Reimbursement for study-related expenses (e.g. travel costs) may be provided.

Study participation will last about 14 weeks and involve about 24 visits to the study centre.

The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines

ClinicalTrials.gov ID




Study Description

  • Brief 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. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in participants with moderate to severe GL. This is a 12 week study in which eligible subjects will be enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 600 adult participants with moderate to severe GL will be enrolled in the study in approximately 38 sites across the world. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive an open-label treatment of AGN-151586 during the study. Participants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

  • Condition or Disease:

    Glabellar Lines

  • Intervention/Treatment:

    Drug: AGN-151586
    Drug: AGN-151586
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:


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.

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.
Participants who have reported use of any botulinum neurotoxin of any serotype (including any investigational botulinum neurotoxin product) for aesthetic treatment within the last 6 months prior to Baseline (Day 1 of treatment) and for therapeutic treatment within the last 12 months prior to study drug administration.
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 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.
Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).

Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.

Participating Locations


Participating Experts

Dr. Wei Jing Loo


Dr. Susan Poelman


Dr. Andrei Metelitsa


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