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This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study.
Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX | Experimental | BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | 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. | 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323) |
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Inclusion Criteria:
- Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period [randomization/treatment with 4-month follow-up visit] and Study Exit visit)
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# 231997 | Glendale | Arizona | 85308 | United States | ||
| Clear Dermatology & Aesthetics Center /ID# 231990 |
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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/
Safety analyses were carried out for the Safety Analysis Set (Safety Population), which consisted of all participants who received study drug in both the lead-in study and in this study (N=292).
A total of 292 participants were enrolled at 28 sites in the United States and Canada. All participants received at least 1 dose of open-label BOTOX and were included in the intent-to-treat (ITT) and safety populations.
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| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323. |
| 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 | Nov 22, 2022 | Nov 7, 2024 |
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| Scottsdale |
| Arizona |
| 85255-4134 |
| United States |
| Clinical Testing of Beverly Hills /ID# 231986 | Encino | California | 91436-2124 | United States |
| Steve Yoelin MD Medical Assoc. Inc /ID# 232004 | Newport Beach | California | 92663-3311 | United States |
| Cosmetic Laser Dermatology /ID# 232414 | San Diego | California | 92121-2119 | United States |
| Ava T. Shamban MD - Santa Monica. /ID# 232000 | Santa Monica | California | 90404-2208 | United States |
| Art of Skin MD /ID# 231995 | Solana Beach | California | 92075-2228 | United States |
| DMR Research PLLC /ID# 231998 | Westport | Connecticut | 06880-5369 | United States |
| Susan H. Weinkle MD /ID# 232001 | Bradenton | Florida | 34209-5642 | United States |
| Research Institute of the Southeast, LLC /ID# 231974 | West Palm Beach | Florida | 33401-2712 | United States |
| Laser and Skin Surgery Center of Indiana /ID# 231983 | Indianapolis | Indiana | 46260-2386 | United States |
| Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977 | Metairie | Louisiana | 70006 | United States |
| Delricht Research /ID# 231985 | New Orleans | Louisiana | 70115 | United States |
| Aesthetic Center at Woodholme /ID# 231996 | Baltimore | Maryland | 21208-6391 | United States |
| Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002 | Hunt Valley | Maryland | 21030-3216 | United States |
| Image Dermatology, P.C. /ID# 231980 | Montclair | New Jersey | 07042 | United States |
| Laser & Skin Surgery Center of New York /ID# 231982 | New York | New York | 10016-4974 | United States |
| Aesthetic Solutions /ID# 231978 | Chapel Hill | North Carolina | 27517-9901 | United States |
| Wilmington Dermatology Center /ID# 231981 | Wilmington | North Carolina | 28403 | United States |
| Aventiv Research Dublin /ID# 231994 | Dublin | Ohio | 43016 | United States |
| KGL Skin Study Center, LLC /ID# 231993 | Newtown Square | Pennsylvania | 19073-2228 | United States |
| Nashville Center for Laser and Facial Surgery /ID# 231975 | Nashville | Tennessee | 37203-1513 | United States |
| Dallas Plastic Surgery Institute /ID# 231999 | Dallas | Texas | 75231 | United States |
| SkinDC /ID# 231989 | Arlington | Virginia | 22209 | United States |
| Premier Clinical Research /ID# 232003 | Spokane | Washington | 99202 | United States |
| Humphrey Cosmetic Dermatology /ID# 239649 | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Dermetics Cosmetic Dermatology /ID# 239650 | Burlington | Ontario | L7N 3N2 | Canada |
| Dr Melinda Gooderham Medicine Profession /ID# 239647 | Cobourg | Ontario | K9A 0Z4 | Canada |
| The Center For Dermatology /ID# 239651 | Richmond Hill | Ontario | L4B 1A5 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| 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. | Safety Analysis Set | Posted | Count of Participants | Participants | 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323) |
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All-cause mortality and adverse event tables include events reported from enrollment in M21-323 to the end of study. The median time participants were followed was 239.0 days.
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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 | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323. | 0 | 292 | 2 | 292 | 42 | 292 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CELLULITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INJECTION SITE BRUISING | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2023 | Nov 7, 2024 | SAP_001.pdf |
| 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 |
|