A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
NCT ID: NCT05248893
Last Updated: 2024-05-29
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
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COMPLETED
PHASE3
986 participants
INTERVENTIONAL
2022-02-25
2023-06-26
Brief Summary
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AGN-151586 is an investigational product being developed for the treatment of GL. Around 940 to 1100 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AGN-151586
Participants will receive 5 intramuscular injections in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may receive up to 2 additional cycles of open-label treatments.
AGN-151586
Intramuscular Injection
Interventions
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AGN-151586
Intramuscular Injection
Eligibility Criteria
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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
* 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).
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Skin Wellness Dermatology - Homewood /ID# 241233
Birmingham, Alabama, United States
Advanced Research Associates - Glendale /ID# 232245
Glendale, Arizona, United States
Skin Care and Laser Physicians of Beverly Hills /ID# 241237
Los Angeles, California, United States
The Eye Research Foundation /ID# 232229
Newport Beach, California, United States
Cosmetic Laser Dermatology /ID# 243513
San Diego, California, United States
UC San Diego Health - University Center Lane - La Jolla /ID# 241243
San Diego, California, United States
Ava T. Shamban MD - Santa Monica. /ID# 241246
Santa Monica, California, United States
Art of Skin MD /ID# 241244
Solana Beach, California, United States
Moradi MD /ID# 241242
Vista, California, United States
AboutSkin Research, LLC /ID# 241702
Greenwood Village, Colorado, United States
Susan H. Weinkle MD /ID# 233835
Bradenton, Florida, United States
Skin Research Institute LLC /ID# 232240
Coral Gables, Florida, United States
Skin and Cancer Associates, LLP /ID# 232228
Miami, Florida, United States
ForCare Clinical Research /ID# 241229
Tampa, Florida, United States
Hamilton Research, LLC /ID# 241232
Alpharetta, Georgia, United States
Atlanta Biomedical Clinical Research /ID# 241258
Atlanta, Georgia, United States
Meridian Clinical Research Dermatology /ID# 241234
Savannah, Georgia, United States
DeNova Research /ID# 232231
Chicago, Illinois, United States
Advanced Dermatology /ID# 241252
Lincolnshire, Illinois, United States
Laser and Skin Surgery Center of Indiana /ID# 233834
Indianapolis, Indiana, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 232230
Metairie, Louisiana, United States
Etre Cosmetic Dermatology and Laser Center /ID# 232235
New Orleans, Louisiana, United States
Visage Dermatology and Aesthetic Center /ID# 241248
Largo, Maryland, United States
Rkmd, Llc /Id# 241239
North Bethesda, Maryland, United States
Michigan Center for Research Company /ID# 241255
Clarkston, Michigan, United States
Rao Dermatology /ID# 243515
Atlantic Highlands, New Jersey, United States
image Dermatology, P.C. /ID# 241227
Montclair, New Jersey, United States
The Rejuva Center /ID# 244285
Latham, New York, United States
Mariwalla Dermatology /ID# 241240
West Islip, New York, United States
Northwest Dermatology Institute /ID# 233498
Portland, Oregon, United States
Perelman Center for Advanced Medicine - /ID# 243966
Philadelphia, Pennsylvania, United States
Sherman Aesthetic Center /ID# 241247
Nashville, Tennessee, United States
Tennessee Clinical Research Center /ID# 241254
Nashville, Tennessee, United States
DermResearch, Inc. Austin, TX /ID# 241228
Austin, Texas, United States
Bellaire Dermatology Associates /ID# 232243
Bellaire, Texas, United States
J&S Studies, Inc. /ID# 241236
College Station, Texas, United States
Dallas Center for Dermatology and Aesthetics /ID# 241245
Dallas, Texas, United States
Swinyer-Woseth Dermatology /ID# 241250
Salt Lake City, Utah, United States
The Education & Research Foundation, Inc. /ID# 241225
Lynchburg, Virginia, United States
Premier Clinical Research /ID# 233836
Spokane, Washington, United States
EthiQ2 Research, LLC /ID# 241256
Brookfield, Wisconsin, United States
Santa Cruz Behavioral (SCB) Research Center /ID# 241226
Bayamón, , Puerto Rico
Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 241241
San Juan, , Puerto Rico
Countries
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Other Identifiers
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M21-509
Identifier Type: -
Identifier Source: org_study_id
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