A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of OnabotulinumtoxinA X for the Treatment of Moderate to Severe Glabellar Lines
1 other identifier
interventional
328
1 country
18
Brief Summary
This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2021
CompletedStudy Start
First participant enrolled
October 6, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2022
CompletedResults Posted
Study results publicly available
September 9, 2025
CompletedSeptember 9, 2025
August 1, 2025
1.2 years
September 30, 2021
August 21, 2025
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale.
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Day 1 to Day 30
Percentage of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Day 1 to Day 270
Secondary Outcomes (3)
Percentage of Participants With Achievement of None or Mild as Rated by Investigator Using the Clinician Glabellar Lines Scale.
Day 1 to Day 30
Percentage of Participants With Achievement of Improvement Per the Facial Lines Satisfaction Questionnaire Impact Domain, Among Subjects With Baseline Scores of 14 Points or Greater.
Day 1 to Day 30
Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5.
Day 1 to Day 60
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X Dose A
EXPERIMENTALOnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X Dose B
EXPERIMENTALOnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X Dose C
EXPERIMENTALOnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.
Interventions
Injection
Eligibility Criteria
You may qualify if:
- Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator.
- Participant has moderate or severe GL at maximum frown.
You may not qualify if:
- History of known immunization to any botulinum toxin serotype.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (18)
Advanced Research Associates - Glendale /ID# 230418
Glendale, Arizona, 85308, United States
Westside Aesthetics /ID# 230305
Los Angeles, California, 90025-1708, United States
The Eye Research Foundation /ID# 232544
Newport Beach, California, 92663-3637, United States
The Research Center at The Maas Clinic /ID# 230685
San Francisco, California, 94115-1809, United States
Center for Dermatology and Dermatologic Surgery /ID# 230684
Washington D.C., District of Columbia, 20037-1445, United States
Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542
Boca Raton, Florida, 33431-6465, United States
Baumann Cosmetic and Research Institute /ID# 232545
Miami, Florida, 33137-3254, United States
Research Institute of the Southeast, LLC /ID# 230436
West Palm Beach, Florida, 33401-2712, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 230693
Metairie, Louisiana, 70006, United States
Etre Cosmetic Dermatology and Laser Center /ID# 230437
New Orleans, Louisiana, 70130-4353, United States
SLUCare Cosmetic Dermatology /ID# 230333
St Louis, Missouri, 63122-3379, United States
Laser & Skin Surgery Center of New York /ID# 230683
New York, New York, 10016-4974, United States
Skin Search of Rochester Inc. /ID# 242540
Rochester, New York, 14623, United States
Aesthetic Solutions /ID# 230716
Chapel Hill, North Carolina, 27517-9901, United States
Wilmington Dermatology Center /ID# 242544
Wilmington, North Carolina, 28403, United States
Aventiv Research Dublin /ID# 232546
Dublin, Ohio, 43016, United States
Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232543
Austin, Texas, 78746-4720, United States
Premier Clinical Research /ID# 230682
Spokane, Washington, 99202, United States
Results Point of Contact
- Title
- ABBVIE CALL CENTER
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 29, 2021
Study Start
October 6, 2021
Primary Completion
December 2, 2022
Study Completion
December 2, 2022
Last Updated
September 9, 2025
Results First Posted
September 9, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.