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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021271-83 | EudraCT Number |
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This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| onabotulinumtoxinA 24U | Other | 24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
|
| placebo (normal saline) | Placebo Comparator | Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
|
| onabotulinumtoxinA 44U | Experimental | 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Drug | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | California | United States | ||||
Extension study for patients who participated in study 191622-099
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| ID | Title | Description |
|---|---|---|
| FG000 | onabotulinumtoxinA 44U | 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. |
| FG001 | onabotulinumtoxinA 24U |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| onabotulinumtoxinA 44 U | Biological | 44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
|
|
| onabotulinumtoxinA 24 U | Biological | 24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
|
|
| Vancouver |
| British Columbia |
| Canada |
| Antibes | France |
| Berlin | Germany |
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. |
| FG002 | Placebo (Normal Saline) | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | onabotulinumtoxinA 44U | 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. |
| BG001 | onabotulinumtoxinA 24U | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. |
| BG002 | Placebo (Normal Saline) | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. |
| BG003 | 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, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | 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 Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported. | Participants from the Intent-to-treat population, consisting of all randomized participants with data available for analysis. | Posted | Number | Percentage of participants | Day 30 |
|
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|
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The safety population (all randomized participants who received study drug) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
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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 | onabotulinumtoxinA 44U | 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. | 6 | 349 | 44 | 349 | ||
| EG001 | onabotulinumtoxinA 24U | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. | 1 | 223 | 23 | 223 | ||
| EG002 | Placebo (Normal Saline) | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. | 1 | 95 | 15 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Infected bites | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haematoma | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| 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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| 45 to 65 Years |
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| >65 Years |
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| Male |
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