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This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose A | Experimental | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
|
| Cohort 2: Dose B | Experimental | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
|
| Cohort 3: Dose C | Experimental | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
|
| Cohort 4: Dose D | Experimental | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaxibotulinumtoxinA for injection | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity. | Week 4 After FHL Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boca Raton site | Boca Raton | Florida | 33431 | United States | ||
| Coral Gables site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: DAXI 40 U GL / 12 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U |
| FG001 | Cohort 2: DAXI 40 U GL / 18 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U |
| FG002 | Cohort 3: DAXI 40 U GL / 24 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U |
| FG003 | Cohort 4: DAXI 40 U GL / 30 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent to treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: DAXI 40 U GL / 12 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U |
| BG001 | Cohort 2: DAXI 40 U GL / 18 U FHL |
| 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 |
| 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 FHL Severity at Maximum Eyebrow Elevation | Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity. | The FHL-evaluable population | Posted | Number | percentage of subjects | Week 4 After FHL Treatment |
|
The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 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 | Cohort 1: DAXI 40 U GL / 12 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenopia | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Domenico Vitarella, Sr. Director, Clinical Development | Revance Therapeutics, Inc. | 510-742-3400 | dvitarella@revance.com |
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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 4, 2019 | Jan 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2020 | Jan 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Coral Gables |
| Florida |
| 33146 |
| United States |
| Toronto, Ontario site | Toronto | Ontario | M5R3N8 | Canada |
| Woodbridge, Ontario site | Woodbridge | Ontario | L4L8E2 | Canada |
DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U
| BG002 | Cohort 3: DAXI 40 U GL / 24 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U |
| BG003 | Cohort 4: DAXI 40 U GL / 30 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U |
| OG002 | Cohort 3: DAXI 40 U GL / 24 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U |
| OG003 | Cohort 4: DAXI 40 U GL / 30 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 5 |
| 14 |
| EG001 | Cohort 2: DAXI 40 U GL / 18 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U. | 0 | 15 | 0 | 15 | 5 | 15 |
| EG002 | Cohort 3: DAXI 40 U GL / 24 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U. | 0 | 16 | 0 | 16 | 5 | 16 |
| EG003 | Cohort 4: DAXI 40 U GL / 30 U FHL | DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U. | 0 | 16 | 0 | 16 | 5 | 16 |
| Dry eye | Eye disorders | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | Non-systematic Assessment |
|
| Oedema | General disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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.
| 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 |