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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 |
|---|---|---|---|---|---|---|
| Encinitas | California | 92024 | 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 |
| Los Angeles |
| California |
| 90069 |
| United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Naperville | Illinois | 60563 | United States |
| New Orleans | Louisiana | 70124 | United States |
| Omaha | Nebraska | 68144 | United States |
| West Islip | New York | 11795 | United States |
| High Point | North Carolina | 27262 | United States |
| Spokane | Washington | 99202 | United States |
| Vancouver | British Columbia | V5Z 4E1 | Canada |
| Burlington | Ontario | L7N 3N2 | Canada |
| Toronto | Ontario | M5R 3N8 | Canada |
| Woodbridge | Ontario | L4L 8E2 | Canada |
| Montreal | Quebec | H3Z 1B7 | Canada |
| 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 | Median | Full Range | years |
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| 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 responders | Week 4 |
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| 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 |
|
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| 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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Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
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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 | 205 | 2 | 205 | 30 | 205 |
| EG001 | Placebo | Biological/Vaccine: Placebo Intramuscular injection Placebo: Intramuscular injection | 0 | 101 | 1 | 101 | 5 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine perforation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Leiomyosarcoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Uterine leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | 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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| 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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