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This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DaxibotulinumtoxinA 40 units | Experimental | Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection |
|
| Placebo | Placebo Comparator | Biological/Vaccine: Placebos Intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxins, Type A | Biological | Intramuscular injection |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group. | 0-36 weeks |
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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 |
|---|---|---|---|
| 31791824 | Derived | Bertucci V, Solish N, Kaufman-Janette J, Yoelin S, Shamban A, Schlessinger J, Snyder D, Gallagher C, Liu Y, Shears G, Rubio RG. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020 Apr;82(4):838-845. doi: 10.1016/j.jaad.2019.06.1313. Epub 2019 Nov 29. | |
| 31609882 |
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Outpatient, male or non-pregnant, non-nursing females, 18-75 years of age, 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 |
| FG001 | Placebo | Biological/Vaccine: Placebo Intramuscular injection Placebo: 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 | Nov 7, 2016 | Feb 15, 2022 |
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| Placebos | Biological | Intramuscular injection |
|
| The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group |
The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group. |
| 0-36 weeks |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Newport Beach | California | 92663 | United States |
| San Francisco | California | 94117 | United States |
| Santa Monica | California | 90404 | United States |
| Greenwood | Colorado | 80111 | United States |
| Boca Raton | Florida | 33431 | United States |
| Coral Gables | Florida | 33146 | United States |
| Chestnut Hill | Massachusetts | 02467 | United States |
| Birmingham | Michigan | 48009 | United States |
| Montclair | New Jersey | 07042 | United States |
| New York | New York | 10001 | United States |
| New York | New York | 10022 | United States |
| Chapel Hill | North Carolina | 27517 | United States |
| Nashville | Tennessee | 37203 | United States |
| Derived |
| Carruthers JD, Fagien S, Joseph JH, Humphrey SD, Biesman BS, Gallagher CJ, Liu Y, Rubio RG; SAKURA 1 and SAKURA 2 Investigator Group; SAKURA 1 and SAKURA 2 Investigator Group includes the following. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020 Jan;145(1):45-58. doi: 10.1097/PRS.0000000000006327. |
| COMPLETED |
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| NOT COMPLETED |
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Intent to treat population
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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 |
| BG001 | Placebo | Biological/Vaccine: Placebo Intramuscular injection Placebo: Intramuscular injection |
| BG002 | Total | Total of all reporting groups |
| 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 | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 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 | Intent to treat population | Posted | Number | percentage of subjects | Week 4 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group. | ITT population | Posted | Median | 95% Confidence Interval | days | 0-36 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group. | ITT population | Posted | Median | 95% Confidence Interval | days | 0-36 weeks |
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The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
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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 | DaxibotulinumtoxinA 40 Units | Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular injection | 0 | 201 | 2 | 201 | 29 | 201 |
| EG001 | Placebo | Biological/Vaccine: Placebo Intramuscular injection Placebo: Intramuscular injection | 0 | 102 | 1 | 102 | 7 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
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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 21, 2017 | 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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| >=65 years |
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| Male |
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| American Indian or Alaska Native American |
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| Native Hawaiian or Other Pacific Islander |
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| Black of African American |
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| More than one race |
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| Unknown or Not Reported |
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| White |
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