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This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | Previous treatment with botulinum toxin Type A for treatment of facial lines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Drug | Previous treatment with botulinum toxin Type A for treatment of facial lines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Total Dose Per Treatment Period | Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-Injection Interval Duration of Each Treatment Period | Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle. | 24 Months |
| Percent of Subjects Reporting Satisfaction With Treatment Effects |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23990584 | Background | Banegas RA, Farache F, Rancati A, Chain M, Gallagher CJ, Chapman MA, Caulkins CA. The South American Glabellar Experience Study (SAGE): a multicenter retrospective analysis of real-world treatment patterns following the introduction of incobotulinumtoxinA in Argentina. Aesthet Surg J. 2013 Sep 1;33(7):1039-45. doi: 10.1177/1090820X13503475. Epub 2013 Aug 29. |
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In this retrospective chart review study, subjects received botulinum toxin Type A (BOTOX®) in study-defined Treatment Periods 1 and 3, and botulinum toxin Type A (Xeomin®) in Treatment Period 2. Data were evaluated as available for each Treatment Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | Previous treatment with botulinum toxin Type A for treatment of facial lines |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | Previous treatment with botulinum toxin Type A for treatment of facial lines |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Average Total Dose Per Treatment Period | Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose. | All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period. | Posted | Mean | Standard Deviation | Units | 24 Months |
|
|
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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 | Botulinum Toxin Type A | Previous treatment with botulinum toxin Type A for treatment of facial lines |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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Percent of subjects reporting satisfaction with treatment effects per chart notes. |
| 24 Months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Inter-Injection Interval Duration of Each Treatment Period | Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle. | All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period. | Posted | Median | Full Range | Days | 24 Months |
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|
|
| Secondary | Percent of Subjects Reporting Satisfaction With Treatment Effects | Percent of subjects reporting satisfaction with treatment effects per chart notes. | All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period. | Posted | Mean | Standard Deviation | Percentage of Subjects | 24 Months |
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| 0 |
| 0 |
| 0 |
| 0 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| 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 |
|
| Title | Measurements |
|---|---|
|