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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo will be injected into the Glabellar Complex on Day 1. |
|
| OnabotulinumtoxinA X Dose A | Experimental | OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1. |
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| OnabotulinumtoxinA X Dose B | Experimental | OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1. |
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| OnabotulinumtoxinA X Dose C | Experimental | OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA X | Drug | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Achievement of None or Mild 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Associates - Glendale /ID# 230418 | Glendale | Arizona | 85308 | United States | ||
| Westside Aesthetics /ID# 230305 |
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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo will be injected into the Glabellar Complex on Day 1. Placebo: Injection |
| FG001 | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1. OnabotulinumtoxinA X: Injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2022 | Aug 21, 2025 |
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| Placebo | Drug | Injection |
|
| 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. |
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. Domain scores are calculated as the mean of transformed item scores on a 0 (low impact) to 100 (highest negative impact) scale. |
| Day 1 to Day 30 |
| Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5. | The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. A score of 100 represents the best score (very satisfied) and a score of 0 represent the worst score (very dissatisfied) on the satisfaction domain or satisfaction single items. | Day 1 to Day 60 |
| 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 |
| FG002 | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1. OnabotulinumtoxinA X: Injection |
| FG003 | OnabotulinumtoxinA X Dose C | OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1. OnabotulinumtoxinA X: Injection |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo was injected into the Glabellar Complex on Day 1. |
| BG001 | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1. |
| BG002 | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1. |
| BG003 | OnabotulinumtoxinA X Dose C | OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Multiple Imputation - Intent-to-Treat Population Estimated responder is the average number of responders across 5 imputed datasets. Confidence interval for responder rate is calculated using normal approximation. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 30 |
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| Primary | 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. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 to Day 270 |
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| Secondary | Percentage of Participants With Achievement of None or Mild 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 | Multiple Imputation - Intent-to-Treat Population Estimated responder is the average number of responders across 5 imputed datasets. Confidence interval for responder rate is calculated using normal approximation. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. Domain scores are calculated as the mean of transformed item scores on a 0 (low impact) to 100 (highest negative impact) scale. | Multiple Imputation - Intent-to-Treat Population Estimated responder is the average number of responders across 5 imputed datasets. Confidence interval for responder rate is calculated using normal approximation. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5. | The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. A score of 100 represents the best score (very satisfied) and a score of 0 represent the worst score (very dissatisfied) on the satisfaction domain or satisfaction single items. | Multiple Imputation - Intent-to-Treat Population Estimated responder is the average number of responders across 5 imputed datasets. Confidence interval for responder rate is calculated using normal approximation. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 60 |
|
All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo was injected into the Glabellar Complex on Day 1. | 0 | 45 | 1 | 45 | 11 | 45 |
| EG001 | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1. | 0 | 90 | 1 | 90 | 15 | 90 |
| EG002 | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1. | 0 | 91 | 0 | 91 | 14 | 91 |
| EG003 | OnabotulinumtoxinA X Dose C | OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1. | 0 | 99 | 2 | 99 | 22 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BUNDLE BRANCH BLOCK RIGHT | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| AMNIOTIC CAVITY INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| INTRACRANIAL ANEURYSM | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EYELID PTOSIS | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| INJECTION SITE OEDEMA | General disorders | MedDRA 25.0 | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | AbbVie | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2022 | Aug 21, 2025 | SAP_001.pdf |
| 26-40 years |
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| 41-55 years |
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| 56-64 years |
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| ≥65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1. |
| OG003 | OnabotulinumtoxinA X Dose C | OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1. |
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OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
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| OnabotulinumtoxinA X Dose C |
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1. |
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| OnabotulinumtoxinA X Dose C |
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1. |
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