Status:
COMPLETED
A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
Lead Sponsor:
Allergan
Conditions:
Glabellar Lines
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-1...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT05248880
Start Date
March 8 2022
End Date
February 1 2023
Last Update
January 10 2024
Active Locations (17)
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1
Clear Dermatology & Aesthetics Center /ID# 238990
Scottsdale, Arizona, United States, 85255-4134
2
Steve Yoelin MD Medical Assoc. Inc /ID# 243197
Newport Beach, California, United States, 92663-3311
3
Marcus Facial Plastic Surgery /ID# 241703
Redondo Beach, California, United States, 90277
4
DMR Research PLLC /ID# 239061
Westport, Connecticut, United States, 06880-5369