Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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 evaluate the safety of AGN-151586 over multiple repeat treatments of the study drug to improve the appearance of glabellar lines. AGN-151586 is an investigational product being developed for the treatment of GL. Around 880 adult participants with moderate to severe GL will be enrolled in the study in approximately 45 sites in the United States. This is an open-label, 126 day study in which all participants will receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive up to 2 additional cycles of treatment 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.

Official Title

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

Keywords

Glabellar Lines AGN-151586

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • Uncontrolled systemic disease.
  • Presence or history of any medical condition that may place the subject 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 toxin 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 screening 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 (SARSCoV-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).

Locations

  • UC San Diego Health - University Center Lane - La Jolla /ID# 241243 accepting new patients
    San Diego California 92122-1013 United States
  • Cosmetic Laser Dermatology /ID# 243513 accepting new patients
    San Diego California 92121-2119 United States
  • Art of Skin MD /ID# 241244 accepting new patients
    Solana Beach California 92075-2228 United States
  • Moradi MD /ID# 241242 accepting new patients
    Vista California 92083-6030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allergan
ID
NCT05248893
Phase
Phase 3 Glabellar Lines Research Study
Study Type
Interventional
Participants
Expecting 880 study participants
Last Updated