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Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL).
This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada.
Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1.
Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX | Experimental | Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOTOX | Drug | Intramuscular Injections |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Responder Status of 'Mostly Satisfied' or 'Very Satisfied' on the Facial Line Satisfaction Questionnaire (FLSQ) Follow Up Item 4 (Satisfaction With the Natural Look) | The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with upper facial lines using the FLSQ 5-point scale where: -2=Very dissatisfied and 2=Very satisfied. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function | The FACE-Q Psychological Function is a 10-item scale that measures psychological function. The responses score ranges from 0 to 100. Higher scores reflect a better outcome. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Wellness Dermatology - Homewood /ID# 248469 | Birmingham | Alabama | 35209-8314 | United States | ||
| The Research Center at The Maas Clinic /ID# 256633 |
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 | BOTOX | Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle 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 | Dec 14, 2023 | Jul 7, 2025 |
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| San Francisco |
| California |
| 94115-1809 |
| United States |
| Pacific Clinical Innovations /ID# 248467 | Vista | California | 92083-6030 | United States |
| Kavali Plastic Surgery and Skin Renewal Center /ID# 248472 | Atlanta | Georgia | 30328 | United States |
| Tennessee Clinical Research Center /ID# 259161 | Nashville | Tennessee | 37215-2885 | United States |
| Integrated Aesthetics - Spring /ID# 257738 | Spring | Texas | 77388 | United States |
| SkinDC /ID# 248470 | Arlington | Virginia | 22209 | United States |
| Skin Matters Medical Aesthetic Centre /ID# 249539 | Vancouver | British Columbia | V6M 4J2 | Canada |
| Project Skin MD - Ottawa /ID# 249718 | Ottawa | Ontario | K1K 2Z7 | Canada |
| Bertucci MedSpa Inc. /ID# 249757 | Woodbridge | Ontario | L4L 8E2 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Modified Intent-to-Treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX | Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Percentage of Participants With Responder Status of 'Mostly Satisfied' or 'Very Satisfied' on the Facial Line Satisfaction Questionnaire (FLSQ) Follow Up Item 4 (Satisfaction With the Natural Look) | The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with upper facial lines using the FLSQ 5-point scale where: -2=Very dissatisfied and 2=Very satisfied. | Modified Intent-to-Treat Population N is Number of subjects with observed measurements at the visit. | Posted | Count of Participants | Participants | Day 30 |
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| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function | The FACE-Q Psychological Function is a 10-item scale that measures psychological function. The responses score ranges from 0 to 100. Higher scores reflect a better outcome. | Modified Intent-to-Treat Population N is Number of participants with observed measurements at both baseline and the given visit. | Posted | Mean | Standard Deviation | units on a scale | Day 30 |
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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 182 days for BOTOX.
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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 | BOTOX | Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1. | 0 | 100 | 0 | 100 | 19 | 100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FACIAL DISCOMFORT | General disorders | MedDRA 27.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| DYSPLASTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| BROW PTOSIS | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AbbVie | ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2025 | Jul 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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| Unknown or Not Reported |
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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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