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| Name | Class |
|---|---|
| ethica Clinical Research Inc. | INDUSTRY |
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The purpose of this study is to demonstrate the safety and duration of effect of 40 Units of prabotulinumtoxinA-xvfs (Jeuveau®) in providing temporary improvement in the appearance of moderate to severe glabellar lines (frown lines, which are the vertical lines that develop between the eyebrows) in adult participants. It will also determine if the duration of effect of 40 Units of Jeuveau® is greater than that of 20 Units of Jeuveau® and 20 Units of Botox® Cosmetic.
This is a multicenter, prospective, randomized, double-blind, active-controlled, single-treatment, increasing dose design. Up to one hundred and fifty subjects will be randomized 1:1:1, to either 20 Units onabotulinumtoxinA (Botox® Cosmetic), 20 Units prabotulinumtoxinA-xvfs (Jeuveau®), or 40 Units prabotulinumtoxinA-xvfs (Jeuveau®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug | Experimental | 40U of PrabotulinumtoxinA-xvfs |
|
| OnabotulinumtoxinA | Active Comparator | 20U of OnabotulinumtoxinA |
|
| PrabotulinumtoxinA-xvfs | Active Comparator | 20U of PrabotulinumtoxinA-xvfs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrabotulinumtoxinA-Xvfs | Drug | One treatment of 40 units |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Effect Described by Kaplan-Meier Analysis | Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units will be assessed for each subject based on the number of days from baseline to the day that the Glabellar Line Scale (GLS) severity, by Investigator Assessment, returns to the baseline value. The treatment will be considered to remain effective for the amount of time during which the GLS severity at maximum frown has not returned to baseline severity. | Duration of effect for each subject will be based on number of days from baseline to the day that Glabellar Line Scale severity (Investigator Assessment) returns to baseline value, assessed every 30 days up to 365 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Avelar, MD | Evolus, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetic Eyelid Plastic Surgery | Boca Raton | Florida | 33431 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Drug | 40U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 40 units |
| FG001 | OnabotulinumtoxinA | 20U of OnabotulinumtoxinA OnabotulinumtoxinA: One treatment of 20 units |
| FG002 | PrabotulinumtoxinA-xvfs | 20U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 20 units |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Drug | 40U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 40 units |
| BG001 | OnabotulinumtoxinA | 20U of OnabotulinumtoxinA OnabotulinumtoxinA: One treatment of 20 units |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Duration of Effect Described by Kaplan-Meier Analysis | Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units will be assessed for each subject based on the number of days from baseline to the day that the Glabellar Line Scale (GLS) severity, by Investigator Assessment, returns to the baseline value. The treatment will be considered to remain effective for the amount of time during which the GLS severity at maximum frown has not returned to baseline severity. | 152 participants comprised the modified intent to treat population; all 152 participants had at least one post-treatment assessment for the primary efficacy endpoint. | Posted | Median | 95% Confidence Interval | Days | Duration of effect for each subject will be based on number of days from baseline to the day that Glabellar Line Scale severity (Investigator Assessment) returns to baseline value, assessed every 30 days up to 365 days. |
|
Adverse event data were collected over a period of up 12 months post treatment.
Adverse events regardless of relationship or seriousness were collected at all study visits from the time of study enrollment until the follow-up or early termination visit period, and could be reported in response to a query, observed by the Investigator or site personnel, or reported spontaneously by the study participant.
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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 | Study Drug | 40U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 40 units |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rui Avelar | Evolus, Inc. | 1-949-284-4689 | rui.avelar@evolus.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 | Nov 23, 2022 | Jun 28, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2023 | Jun 28, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000630868 | prabotulinumtoxin A |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| OnabotulinumtoxinA | Drug | One treatment of 20 units |
|
|
| PrabotulinumtoxinA-Xvfs | Drug | One treatment of 20 units |
|
|
| Moved; too much driving |
|
| Did not receive treatment |
|
| BG002 | PrabotulinumtoxinA-xvfs | 20U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 20 units |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participant Has a Prior history of botulinum toxin use | Participants were asked if they had ever been treated with botulinum toxin for any indication and participants responded yes or no | Count of Participants | Participants |
|
| Glabellar Line Score of Moderate at Maximum Frown by Investigator Assessment | Validated 4-point Glabellar Line Scale (GLS): 0=None/No lines, 1=Mild/Line seen, not sharp, 2=Moderate/Line sharper, deep, may see heaping of skin; 3=Severe/Deeper line, heaping of skin, skin may be opposed | Count of Participants | Participants |
|
| Glabellar Line Score of Moderate at Maximum Frown by Subject Assessment | Validated 4-point Glabellar Line Scale (GLS): 0=None/No lines, 1=Mild/Line seen, not sharp, 2=Moderate/Line sharper, deep, may see heaping of skin; 3=Severe/Deeper line, heaping of skin, skin may be opposed | Count of Participants | Participants |
|
| Glabellar Line Score of Severe at Maximum Frown by Investigator Assessment | VValidated 4-point Glabellar Line Scale (GLS): 0=None/No lines, 1=Mild/Line seen, not sharp, 2=Moderate/Line sharper, deep, may see heaping of skin; 3=Severe/Deeper line, heaping of skin, skin may be opposed | Count of Participants | Participants |
|
| Glabellar Line Score of Severe at Maximum Frown by Subject Assessment | Validated 4-point Glabellar Line Scale (GLS): 0=None/No lines, 1=Mild/Line seen, not sharp, 2=Moderate/Line sharper, deep, may see heaping of skin; 3=Severe/Deeper line, heaping of skin, skin may be opposed | Count of Participants | Participants |
|
40U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 40 units |
| OG001 | OnabotulinumtoxinA | 20U of OnabotulinumtoxinA OnabotulinumtoxinA: One treatment of 20 units |
| OG002 | PrabotulinumtoxinA-xvfs | 20U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 20 units |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 2 |
| 51 |
| EG001 | OnabotulinumtoxinA | 20U of OnabotulinumtoxinA OnabotulinumtoxinA: One treatment of 20 units | 0 | 50 | 0 | 50 | 5 | 50 |
| EG002 | PrabotulinumtoxinA-xvfs | 20U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 20 units | 0 | 53 | 0 | 53 | 3 | 52 |
| COVID-19 | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the Study Sponsor. Any Investigator involved with this study is obligated to provide the Sponsor with complete test results and all data derived from the study.
| 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 |