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This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAXI 40 U GL / 32 U FHL / 48 U LCL | Experimental | DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), & Lateral Canthal Lines (LCL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaxibotulinumtoxinA for injection | Drug | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With None or Mild in GL Severity at Maximum Frown | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS | Week 4 |
| Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS | Week 4 |
| Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Manhattan Beach | California | 90266 | United States | ||
| Site 3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36533798 | Derived | Dover JS, Humphrey SD, Lorenc ZP, Shamban A, Gross TM, Rubio RG, Vitarella D. Treatment of Upper Facial Lines With DaxibotulinumtoxinA for Injection: Results From an Open-Label Phase 2 Study. Dermatol Surg. 2023 Jan 1;49(1):60-65. doi: 10.1097/DSS.0000000000003637. Epub 2022 Nov 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DAXI 40 U GL / 32 U FHL / 48 U LCL | DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), & Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: 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 | Oct 25, 2019 | Jun 1, 2023 |
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| San Diego |
| California |
| 92121 |
| United States |
| Site 7 | Santa Monica | California | 90404 | United States |
| Site 5 | Coral Gables | Florida | 33146 | United States |
| Site 2 | Chestnut Hill | Massachusetts | 02467 | United States |
| Site 6 | New York | New York | 10028 | United States |
| Site 4 | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Site 8 | Toronto | Ontario | M5R3N8 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | DAXI 40 U GL / 32 U FHL / 48 U LCL | DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), & Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: 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 | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Percentage of Participants With None or Mild in GL Severity at Maximum Frown | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS | Evaluable population | Posted | Count of Participants | Participants | Week 4 |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS | Evaluable population | Posted | Count of Participants | Participants | Week 4 |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS | Evaluable population | Posted | Count of Participants | Participants | Week 4 |
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The adverse events were collected throughout the entire study, up to 36 weeks after treatment.
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 | DAXI 40 U GL / 32 U FHL / 48 U LCL | DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), & Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: Intramuscular injection | 0 | 48 | 1 | 48 | 3 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | Systematic Assessment |
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The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication 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, (ii)to identify any Confidential Information to be deleted from the proposed publication or disclosure, and (iii)or delay the publication or disclosure 90 days to allow Revance to pursue patent protections.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Gross, PhD, VP, Clinical Development & Data Science | Revance Therapeutics, Inc. | 510-742-3400 | tgross@revance.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2020 | Jun 1, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| 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 |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Other |
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