A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
NCT ID: NCT05100199
Last Updated: 2025-09-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
328 participants
INTERVENTIONAL
2021-10-06
2022-12-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
NCT05013424
A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines
NCT05152576
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 to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines
NCT05496335
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
NCT01485601
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
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo will be injected into the Glabellar Complex on Day 1.
Placebo
Injection
OnabotulinumtoxinA X Dose A
OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X
Injection
OnabotulinumtoxinA X Dose B
OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X
Injection
OnabotulinumtoxinA X Dose C
OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X
Injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OnabotulinumtoxinA X
Injection
Placebo
Injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participant has moderate or severe GL at maximum frown.
Exclusion Criteria
* History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
* Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X 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.
* Facial nerve palsy.
* Infection or dermatological condition at the site of study drug injection.
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.
Advanced Research Associates - Glendale /ID# 230418
Glendale, Arizona, United States
Westside Aesthetics /ID# 230305
Los Angeles, California, United States
The Eye Research Foundation /ID# 232544
Newport Beach, California, United States
The Research Center at The Maas Clinic /ID# 230685
San Francisco, California, United States
Center for Dermatology and Dermatologic Surgery /ID# 230684
Washington D.C., District of Columbia, United States
Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542
Boca Raton, Florida, United States
Baumann Cosmetic and Research Institute /ID# 232545
Miami, Florida, United States
Research Institute of the Southeast, LLC /ID# 230436
West Palm Beach, Florida, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 230693
Metairie, Louisiana, United States
Etre Cosmetic Dermatology and Laser Center /ID# 230437
New Orleans, Louisiana, United States
SLUCare Cosmetic Dermatology /ID# 230333
St Louis, Missouri, United States
Laser & Skin Surgery Center of New York /ID# 230683
New York, New York, United States
Skin Search of Rochester Inc. /ID# 242540
Rochester, New York, United States
Aesthetic Solutions /ID# 230716
Chapel Hill, North Carolina, United States
Wilmington Dermatology Center /ID# 242544
Wilmington, North Carolina, United States
Aventiv Research Dublin /ID# 232546
Dublin, Ohio, United States
Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232543
Austin, Texas, United States
Premier Clinical Research /ID# 230682
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2042-201-008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.