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Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines.
Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States.
Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo will be injected into the forehead on Day 1. |
|
| OnabotulinumtoxinA X Dose A | Experimental | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
|
| OnabotulinumtoxinA X Dose B | Experimental | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
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| OnabotulinumtoxinA X Dose C | Experimental | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA X | Drug | Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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 casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the 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. | Day 1 to Day 180 |
| Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters | Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed. | Day 1 to Day 180 |
| Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction. | Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe. | Day 1 to Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Research Foundation /ID# 241512 | Newport Beach | California | 92663-3637 | United States | ||
| Steve Yoelin MD Medical Associate Inc /ID# 239771 |
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| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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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 forehead on Day 1. |
| FG001 | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| 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 | Jul 18, 2022 | Jun 27, 2025 |
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|
| Placebo | Drug | Intramuscular Injection |
|
| Newport Beach |
| California |
| 92663 |
| United States |
| The Center for Dermatology Cosmetics & Laser Surgery /ID# 239776 | Mount Kisco | New York | 10549-3028 | United States |
| Skin Search of Rochester Inc. /ID# 239773 | Rochester | New York | 14623 | United States |
| Dermatology Consulting Service /ID# 239779 | High Point | North Carolina | 27262 | United States |
| Wilmington Dermatology Center /ID# 239778 | Wilmington | North Carolina | 28403 | United States |
| Dallas Plastic Surgery Institute /ID# 239777 | Dallas | Texas | 75231 | United States |
| Duplicate_Austin Institute for Clinical Research /ID# 239783 | Pflugerville | Texas | 78660 | United States |
| FG002 | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| FG003 | OnabotulinumtoxinA X Dose C | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo will be injected into the forehead on Day 1. |
| BG001 | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| BG002 | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| BG003 | OnabotulinumtoxinA X Dose C | OnabotulinumtoxinA X will be injected into the forehead 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 |
| |||||||||||||||
| 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 |
| ||||||||||||||||
| 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 | Number of Participants With Adverse Events | 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 casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the 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. | Safety population | Posted | Count of Participants | Participants | Day 1 to Day 180 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters | Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed. | Safety population Overall Number of Participants Analyzed = Except for Temperature, number of subjects with an available baseline value and at least 1 postbaseline assessment; for Temperature, number of subjects with at least 1 postbaseline assessment. | Posted | Count of Participants | Participants | Day 1 to Day 180 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction. | Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe. | Intent-to-Treat Population Overall Number of Participants Analyzed = Number of subjects with data at baseline and the visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 30 |
|
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 190, 190, 191, and 189 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 will be injected into the forehead on Day 1. | 0 | 30 | 1 | 30 | 4 | 30 |
| EG001 | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X will be injected into the forehead on Day 1. | 0 | 35 | 0 | 35 | 5 | 35 |
| EG002 | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X will be injected into the forehead on Day 1. | 0 | 31 | 0 | 31 | 10 | 31 |
| EG003 | OnabotulinumtoxinA X Dose C | OnabotulinumtoxinA X will be injected into the forehead on Day 1. | 0 | 28 | 0 | 28 | 9 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| KIDNEY INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EYELID PTOSIS | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INJECTION SITE BRUISING | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INJECTION SITE SWELLING | General disorders | MedDRA 25.0 | Systematic Assessment |
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| ASYMPTOMATIC COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | 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 | Sep 12, 2022 | Jun 27, 2025 | SAP_001.pdf |
| 26-40 |
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| 41-55 |
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| 56-64 |
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| >=65 |
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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 will be injected into the forehead on Day 1.
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