A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
NCT ID: NCT05248880
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
309 participants
INTERVENTIONAL
2022-03-08
2023-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 300 adult participants with moderate to severe GL will be enrolled in the study in approximately 15 sites.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
NCT05248867
A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines
NCT05496335
A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
NCT06499688
A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
NCT06583486
Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines
NCT01271452
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AGN-151586
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586
Intramuscular Injection
Placebo
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586
Intramuscular Injection
Placebo
Intramuscular Injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AGN-151586
Intramuscular Injection
Placebo
Intramuscular Injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clear Dermatology & Aesthetics Center /ID# 238990
Scottsdale, Arizona, United States
Steve Yoelin MD Medical Assoc. Inc /ID# 243197
Newport Beach, California, United States
Marcus Facial Plastic Surgery /ID# 241703
Redondo Beach, California, United States
DMR Research PLLC /ID# 239061
Westport, Connecticut, United States
Kavali Plastic Surgery /ID# 244808
Atlanta, Georgia, United States
Delricht Research - 10154 Jefferson /ID# 244890
Baton Rouge, Louisiana, United States
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067
Hunt Valley, Maryland, United States
Wilmington Dermatology Center /ID# 233935
Wilmington, North Carolina, United States
Clinical Research Center of the Carolinas /ID# 239064
Charleston, South Carolina, United States
Austin Institute for Clinical Research /ID# 238989
Pflugerville, Texas, United States
Kalo Clinical Research /ID# 247279
West Valley City, Utah, United States
SkinDC /ID# 238988
Arlington, Virginia, United States
YVR Aesthetics Training & Study Centre /ID# 241858
Vancouver, British Columbia, Canada
Pacific Derm /ID# 239654
Vancouver, British Columbia, Canada
Dr Melinda Gooderham Medicine Profession /ID# 239657
Cobourg, Ontario, Canada
The Centre for Clinical Trials /ID# 245873
Oakville, Ontario, Canada
Clinique D /ID# 239653
Laval, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M21-508
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.