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This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A (40 Units) | Active Comparator | Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. |
|
| botulinum toxin Type A (30 Units) | Active Comparator | Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. |
|
| placebo (Normal saline) | Placebo Comparator | Placebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30. | Day 30 |
| Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines | Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at 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 |
|---|---|---|---|---|---|---|
| Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26863598 | Background | Solish N, Rivers JK, Humphrey S, Muhn C, Somogyi C, Lei X, Bhogal M, Caulkins C. Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial. Dermatol Surg. 2016 Mar;42(3):410-9. doi: 10.1097/DSS.0000000000000626. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A (40 Units) | Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. |
| FG001 | Botulinum Toxin Type A (30 Units) | Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. |
| FG002 | Placebo (Normal Saline) | Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A (40 Units) | Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. |
| BG001 | Botulinum Toxin Type A (30 Units) |
| 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 Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30. | Intent-to-treat population included all randomized participants. | Posted | Number | Percentage of participants | Day 30 |
|
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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 (40 Units) | Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nerve compression | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | 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 | Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1. |
|
| Day 30 |
| Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest | The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline. | Baseline, Day 30 |
| Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest | Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline. | Baseline, Day 30 |
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
| BG002 | Placebo (Normal Saline) | Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. |
| OG002 | Placebo (Normal Saline) | Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1. |
|
|
| Primary | Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30. | Intent-to-treat population included all randomized participants. | Posted | Number | Percentage of participants | Day 30 |
|
|
|
| Secondary | Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines | Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30. | Includes participants from the Intent-to-treat Population (all randomized participants) with a rating of very unsatisfied, unsatisfied or neutral in the Subject's Assessment of Satisfaction of Appearance at baseline. | Posted | Number | Percentage of participants | Day 30 |
|
|
|
| Secondary | Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest | The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline. | Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline. | Posted | Number | Percentage of participants | Baseline, Day 30 |
|
|
|
| Secondary | Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest | Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline. | Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline. | Posted | Number | Percentage of participants | Baseline, Day 30 |
|
|
|
| 0 |
| 57 |
| 2 |
| 57 |
| EG001 | Botulinum Toxin Type A (30 Units) | Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. | 0 | 60 | 8 | 60 |
| EG002 | Placebo (Normal Saline) | Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1. | 1 | 58 | 8 | 58 |
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | 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 |