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This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | Active Comparator | Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. |
|
| placebo (Normal Saline) | Placebo Comparator | Normal Saline (placebo) injected into the glabellar region on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 | Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30 | The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild. |
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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 |
|---|---|---|---|---|---|---|
| East Chicago | Illinois | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. |
| FG001 | Placebo (Normal Saline) | Normal Saline (placebo) injected into the glabellar region on Day 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. |
| BG001 | Placebo (Normal Saline) | Normal Saline (placebo) injected into the glabellar region on Day 0. |
| 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 | Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 | Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved. | Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point. | Posted | Number | Percentage of participants | Day 30 |
|
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Serious adverse events and adverse events were assessed in all participants with at least 1 post-baseline assessment.
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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 | Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coughing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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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 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| normal saline (placebo) | Drug | Normal saline (placebo) injected into the glabellar region on Day 0. |
|
| Day 30 |
| Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60 | The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild. | Day 60 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo (Normal Saline) | Normal Saline (placebo) injected into the glabellar region on Day 0. |
|
|
| Secondary | Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30 | The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild. | Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point. | Posted | Number | Percentage of participants | Day 30 |
|
|
|
| Secondary | Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60 | The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild. | Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point. | Posted | Number | Percentage of participants | Day 60 |
|
|
|
| 0 |
| 19 |
| 2 |
| 19 |
| EG001 | Placebo (Normal Saline) | Normal Saline (placebo) injected into the glabellar region on Day 0. | 0 | 20 | 0 | 20 |
| Very small bruise | General disorders | Non-systematic Assessment |
|
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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |