Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. |
|
| BOTOX® Low Dose | Experimental | Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
|
| BOTOX® High Dose | Active Comparator | Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOTOX® purified neurotoxin complex | Drug | BOTOX® superficial intramuscular injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS) | The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis. | Day 14 |
| Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE) | 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 drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention. | From the first dose of study drug up to end of study (up to Day 120) |
| Pulse Rate at Baseline | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline (Day 1) |
| Change From Baseline in Pulse Rate at Day 7 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 7 |
| Change From Baseline in Pulse Rate at Day 14 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS) | The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis. |
Not provided
Inclusion Criteria:
Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care and Laser Physicians of Beverly Hills /ID# 236518 | Los Angeles | California | 90069 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41933889 | Derived | Humphrey S, Shimoga S, Kaufman J, Bank D, Biesman B, Harutunian C, West GS, Tong W, Patel V. Patient-Reported Outcomes After Treatment With OnabotulinumtoxinA for Platysma Prominence: Results From a Phase 2 Dose-Ranging Study. J Cosmet Dermatol. 2026 Apr;25(4):e70821. doi: 10.1111/jocd.70821. | |
| 40704633 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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/
Participant flow and all-cause mortality tables are based on all participants randomized on Day 1. Adverse events are reported for safety population, which included all participants who were administered study intervention.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| FG001 | BOTOX® Low Dose | Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| FG002 | BOTOX® High Dose | Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| BG001 | BOTOX® Low Dose | Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma 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 |
| 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 at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS) | The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis. | mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 14 |
|
All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| THROMBOCYTOSIS | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INJECTION SITE BRUISING | General disorders | MedDRA 23.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 12, 2019 | Apr 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2020 | Apr 11, 2023 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo injections. |
|
| Baseline; Day 14 |
| Change From Baseline in Pulse Rate at Day 30 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 30 |
| Change From Baseline in Pulse Rate at Day 60 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 60 |
| Change From Baseline in Pulse Rate at Day 90 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 90 |
| Change From Baseline in Pulse Rate at Day 120 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 120 |
| Systolic and Diastolic Blood Pressure (BP) at Baseline | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline (Day 1) |
| Change From Baseline in Systolic and Diastolic BP at Day 7 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 7 |
| Change From Baseline in Systolic and Diastolic BP at Day 14 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 14 |
| Change From Baseline in Systolic and Diastolic BP at Day 30 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 30 |
| Change From Baseline in Systolic and Diastolic BP at Day 60 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 60 |
| Change From Baseline in Systolic and Diastolic BP at Day 90 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 90 |
| Change From Baseline in Systolic and Diastolic BP at Day 120 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 120 |
| Respiratory Rate at Baseline | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline (Day 1) |
| Change From Baseline in Respiratory Rate at Day 7 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 7 |
| Change From Baseline in Respiratory Rate at Day 14 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 14 |
| Change From Baseline in Respiratory Rate at Day 30 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 30 |
| Change From Baseline in Respiratory Rate at Day 60 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 60 |
| Change From Baseline in Respiratory Rate at Day 90 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 90 |
| Change From Baseline in Respiratory Rate at Day 120 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 120 |
| Day 14 |
| Skin Research Institute LLC /ID# 238126 |
| Coral Gables |
| Florida |
| 33146-1837 |
| United States |
| DeNova Research /ID# 238165 | Chicago | Illinois | 60611 | United States |
| MD Laser Skin & Vein /ID# 234532 | Hunt Valley | Maryland | 21030 | United States |
| The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624 | Mount Kisco | New York | 10549-3028 | United States |
| The Practice of Brian S. Biesman MD PLLC /ID# 234461 | Nashville | Tennessee | 37203 | United States |
| Dallas Plastic Surgery Institute /ID# 236528 | Dallas | Texas | 75231 | United States |
| Humphrey Cosmetic Dermatology /ID# 236591 | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Pacific Derm /ID# 238236 | Vancouver | British Columbia | V6H 4E1 | Canada |
| Dermetics Cosmetic Dermatology /ID# 236899 | Burlington | Ontario | L7N 3N2 | Canada |
| Sweat Clinics of Canada /ID# 236590 | Toronto | Ontario | M5R 3N8 | Canada |
| Bertucci MedSpa Inc. /ID# 236523 | Woodbridge | Ontario | L4L 8E2 | Canada |
| Garcia JK, Hopfinger RM, Foley C, Whyte J, Gauthier M, Foster B, Patel V. Development and validation of patient-reported outcome measures for platysma prominence. Curr Med Res Opin. 2025 Jul;41(7):1277-1290. doi: 10.1080/03007995.2025.2537898. Epub 2025 Jul 31. |
| 38640068 | Derived | Rohrich RJ, Bertucci V, Dayan S, Jones D, Solish N, Rivers JK, Weiss RA, Muhn CY, Harutunian C, Park GS, Shimoga S, Lee E, Tong W. Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study. Plast Reconstr Surg. 2025 Jan 1;155(1):79-88. doi: 10.1097/PRS.0000000000011472. Epub 2024 Apr 16. |
| Lost to Follow-up |
|
| Protocol Deviation |
|
| Covid-19 Related Issues |
|
| Randomized With Incorrect C-APPS |
|
| BG002 | BOTOX® High Dose | Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| OG001 | BOTOX® Low Dose | Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
| OG002 | BOTOX® High Dose | Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. |
|
|
|
| Primary | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE) | 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 drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention. | Safety population included all participants who were administered study intervention. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of study (up to Day 120) |
|
|
|
| Primary | Pulse Rate at Baseline | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Safety population included all participants who were administered study intervention. | Posted | Mean | Standard Deviation | beats per minute (beats/min) | Baseline (Day 1) |
|
|
|
| Primary | Change From Baseline in Pulse Rate at Day 7 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | beats/min | Baseline; Day 7 |
|
|
|
| Primary | Change From Baseline in Pulse Rate at Day 14 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | beats/min | Baseline; Day 14 |
|
|
|
| Primary | Change From Baseline in Pulse Rate at Day 30 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | beats/min | Baseline; Day 30 |
|
|
|
| Primary | Change From Baseline in Pulse Rate at Day 60 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | beats/min | Baseline; Day 60 |
|
|
|
| Primary | Change From Baseline in Pulse Rate at Day 90 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | beats/min | Baseline; Day 90 |
|
|
|
| Primary | Change From Baseline in Pulse Rate at Day 120 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | beats/min | Baseline; Day 120 |
|
|
|
| Primary | Systolic and Diastolic Blood Pressure (BP) at Baseline | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Safety population included all participants who were administered study intervention. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline (Day 1) |
|
|
|
| Primary | Change From Baseline in Systolic and Diastolic BP at Day 7 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | mmHg | Baseline; Day 7 |
|
|
|
| Primary | Change From Baseline in Systolic and Diastolic BP at Day 14 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | mmHg | Baseline; Day 14 |
|
|
|
| Primary | Change From Baseline in Systolic and Diastolic BP at Day 30 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | mmHg | Baseline; Day 30 |
|
|
|
| Primary | Change From Baseline in Systolic and Diastolic BP at Day 60 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | mmHg | Baseline; Day 60 |
|
|
|
| Primary | Change From Baseline in Systolic and Diastolic BP at Day 90 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | mmHg | Baseline; Day 90 |
|
|
|
| Primary | Change From Baseline in Systolic and Diastolic BP at Day 120 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | mmHg | Baseline; Day 120 |
|
|
|
| Primary | Respiratory Rate at Baseline | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Safety population included all participants who were administered study intervention. | Posted | Mean | Standard Deviation | breaths per minute (breaths/min) | Baseline (Day 1) |
|
|
|
| Primary | Change From Baseline in Respiratory Rate at Day 7 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | breaths/min | Baseline; Day 7 |
|
|
|
| Primary | Change From Baseline in Respiratory Rate at Day 14 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | breaths/min | Baseline; Day 14 |
|
|
|
| Primary | Change From Baseline in Respiratory Rate at Day 30 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | breaths/min | Baseline; Day 30 |
|
|
|
| Primary | Change From Baseline in Respiratory Rate at Day 60 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | breaths/min | Baseline; Day 60 |
|
|
|
| Primary | Change From Baseline in Respiratory Rate at Day 90 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | breaths/min | Baseline; Day 90 |
|
|
|
| Primary | Change From Baseline in Respiratory Rate at Day 120 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | breaths/min | Baseline; Day 120 |
|
|
|
| Secondary | Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS) | The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis. | mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 14 |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 56 |
| 10 |
| 56 |
| EG001 | BOTOX® Low Dose | Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. | 0 | 59 | 2 | 59 | 6 | 59 |
| EG002 | BOTOX® High Dose | Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. | 0 | 55 | 0 | 54 | 8 | 54 |
| APPENDICITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| INJECTION SITE HAEMORRHAGE | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
|
|
|
|
|
|
|
| <0.0001 |
P-value derived from CMH model stratified by investigator site and P-APPS at Day 1. |
| Rate Difference |
| 70.2 |
| 2-Sided |
| 95 |
| 56.4 |
| 84.1 |
| Superiority |