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This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DaxibotulinumtoxinA 40 units | Experimental | Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxins, Type A | Biological | Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAE) | Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period. | 0-36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e. none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32773447 | Derived | Green JB, Mariwalla K, Coleman K, Ablon G, Weinkle SH, Gallagher CJ, Vitarella D, Rubio RG. A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study. Dermatol Surg. 2021 Jan 1;47(1):42-46. doi: 10.1097/DSS.0000000000002463. | |
| 32773446 | Derived |
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Outpatient, male or non-pregnant, non-nursing females, 18 years of age or older, and in good general health with moderate (2) or severe (3) glabellar lines during maximum frown based on the IGA-FWS and PFWS.
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| ID | Title | Description |
|---|---|---|
| FG000 | DaxibotulinumtoxinA 40 Units | Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular 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 | Mar 20, 2017 | Feb 15, 2022 |
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| The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle. | 0-36 weeks per cycles 1 and 2 |
| The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle. | 0-36 weeks per Cycle 1 and 2 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Encinitas | California | 92024 | United States |
| Fremont | California | 94538 | United States |
| Los Angeles | California | 90069 | United States |
| Manhattan Beach | California | 90266 | United States |
| Newport Beach | California | 92663 | United States |
| Roseville | California | 95661 | United States |
| Sacramento | California | 95819 | United States |
| San Diego | California | 92121 | United States |
| San Diego | California | 92122 | United States |
| San Francisco | California | 94117 | United States |
| Santa Monica | California | 90404 | United States |
| Greenwood Village | Colorado | 80111 | United States |
| Washington D.C. | District of Columbia | 20007 | United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Boca Raton | Florida | 33431 | United States |
| Bradenton | Florida | 34209 | United States |
| Coral Gables | Florida | 33146 | United States |
| Miami | Florida | 33137 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Chicago | Illinois | 60611 | United States |
| Lincolnshire | Illinois | 60069 | United States |
| Naperville | Illinois | 60563 | United States |
| New Orleans | Louisiana | 70124 | United States |
| New Orleans | Louisiana | 70130 | United States |
| Baltimore | Maryland | 21208 | United States |
| Glenn Dale | Maryland | 20769 | United States |
| Hunt Valley | Maryland | 21030 | United States |
| Rockville | Maryland | 20850 | United States |
| Chestnut Hill | Massachusetts | 27517 | United States |
| Birmingham | Michigan | 48009 | United States |
| Fridley | Minnesota | 55432 | United States |
| St Louis | Missouri | 63122 | United States |
| Omaha | Nebraska | 68144 | United States |
| Montclair | New Jersey | 07042 | United States |
| New York | New York | 10011 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10022 | United States |
| New York | New York | 10028 | United States |
| New York | New York | 10029 | United States |
| New York | New York | 10075 | United States |
| West Islip | New York | 11795 | United States |
| White Plains | New York | 10604 | United States |
| Chapel Hill | North Carolina | 27517 | United States |
| Charlotte | North Carolina | 28207 | United States |
| High Point | North Carolina | 27262 | United States |
| Portland | Oregon | 97223 | United States |
| Drexel Hill | Pennsylvania | 19026 | United States |
| Nashville | Tennessee | 37203 | United States |
| Nashville | Tennessee | 37215 | United States |
| Austin | Texas | 78746 | United States |
| College Station | Texas | 77845 | United States |
| Houston | Texas | 77056 | United States |
| Katy | Texas | 77494 | United States |
| Mequon | Wisconsin | 53092 | United States |
| Vancouver | British Columbia | V5Z 4E1 | Canada |
| Burlington | Ontario | L7N 3N2 | Canada |
| Toronto | Ontario | M5R3N8 | Canada |
| Woodbridge | Ontario | L4L 8E2 | Canada |
| Montreal | Quebec | H3Z 1BZ | Canada |
| Fabi SG, Cohen JL, Green LJ, Dhawan S, Kontis TC, Baumann L, Gross TM, Gallagher CJ, Brown J, Rubio RG. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. Dermatol Surg. 2021 Jan 1;47(1):48-54. doi: 10.1097/DSS.0000000000002531. |
| Received a Single Treatment |
|
| Received Two Treatments |
|
| Received Three Treatments |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Safety population consisting of all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | DaxibotulinumtoxinA 40 Units | Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Incidence of Treatment Emergent Adverse Events (TEAE) | Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period. | Safety Evaluable Population | Posted | Count of Participants | Participants | 0-36 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e. none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments | Safety Evaluable Population | Posted | Number | percentage of responders | Week 4 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle. | Safety Evaluable Population | Posted | Median | 95% Confidence Interval | days | 0-36 weeks per cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle. | Safety Evaluable Population | Posted | Median | 95% Confidence Interval | days | 0-36 weeks per Cycle 1 and 2 |
|
|
0-54 weeks
Does not differ than the Clinicaltrials.gov definition
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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 | Overall | Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection | 1 | 2,691 | 29 | 2,691 | 158 | 2,691 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Impaired gastric emptying | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatis acute | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cholecystitis infective | Infections and infestations | Non-systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Pelvic inflammatory disease | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Rib fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Upper limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Invasive ductal breat carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Optic neuritis | Nervous system disorders | Non-systematic Assessment |
| ||
| Parasthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Adenomyosis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
With respect to any proposed publication or disclosure of the results of the Study, the Study Center and Investigator shall submit to Revance a copy of the proposed publication or disclosure at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i) to provide Revance with the opportunity to review and comment on the contents thereof, and (ii) to identify any Confidential Information to be deleted from the proposed publication or disclosure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Gross, PhD, VP Data Science, Interim Head of Clinical Development | Revance Therapeutics, Inc. | 510-742-3400 | tgross@revance.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2018 | Feb 15, 2022 | 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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| Others |
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| Asian |
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| Participants |
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