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This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® | Active Comparator | BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1. |
|
| Placebo | Placebo Comparator | Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) | Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported. | Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ | Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants mostly or very satisfied is reported. |
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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 |
|---|---|---|---|---|---|---|
| Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26218728 | Background | Rivers JK, Bertucci V, McGillivray W, Muhn C, Rosen N, Solish N, Weichman BM, Wheeler S, Daniels SR, Gallagher CJ. Subject satisfaction with onabotulinumtoxinA treatment of glabellar and lateral canthal lines using a new patient-reported outcome measure. Dermatol Surg. 2015 Aug;41(8):950-9. doi: 10.1097/DSS.0000000000000424. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX® | BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1. |
| FG001 | Placebo | Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline measures are based on the Per-Protocol population that included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® | BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1. |
| BG001 | Placebo | Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1. |
| 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 | Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) | Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 60 |
|
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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 | BOTOX® | BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 15.1 | 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 | Drug | Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1. |
|
| Day 60 |
| Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ | Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported. | Day 90 |
| Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ | Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported. | Day 60 |
| Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported. | Day 90 |
| Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ | Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported. | Day 60 |
| Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ | Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported. | Day 90 |
| Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported. | Day 90 |
| Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS | The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported. | Day 30 |
| Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS | The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported. | Baseline, Day 30 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1. |
|
|
| Secondary | Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ | Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants mostly or very satisfied is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 60 |
|
|
|
| Secondary | Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ | Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 90 |
|
|
|
| Secondary | Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ | Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 60 |
|
|
|
| Secondary | Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 90 |
|
|
|
| Secondary | Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ | Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 60 |
|
|
|
| Secondary | Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ | Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 90 |
|
|
|
| Secondary | Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 90 |
|
|
|
| Secondary | Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS | The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Day 30 |
|
|
|
| Secondary | Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS | The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported. | Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations. | Posted | Number | Percentage of participants | Baseline, Day 30 |
|
|
|
| 1 |
| 63 |
| 6 |
| 63 |
| EG001 | Placebo | Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1. | 0 | 62 | 4 | 62 |
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| 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 |