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This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin Type A (44U) | Experimental | 44 units (U) botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
|
| Botulinum toxin Type A (32U) | Experimental | 32 units (U) botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A (44U) | Biological | 44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL) | Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported. |
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Inclusion Criteria:
-Moderate to severe Crow's Feet Lines and Frown Lines
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A (44U) | 44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
| FG001 | Botulinum Toxin Type A (32U) | 32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A (44U) | 44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
| BG001 |
| 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 None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 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. | Intent-to-treat population included all enrolled participants. | Posted | Number | percentage of participants | Day 30 |
|
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The Safety Population, all enrolled participants who received study drug, was used to determine 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 | Botulinum Toxin Type A (44U) | 44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis A | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| botulinum toxin Type A (32U) | Biological | 32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area. |
|
|
| Day 30 |
| Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : "When I look in the mirror, my facial lines make me look older than I want to look" score. | Baseline, Day 30 |
| Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: "My facial lines make me look less attractive than I want to look" score. | Baseline, Day 30 |
| Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: "My facial lines make me look tired" score. | Baseline, Day 30 |
| Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | Participants were considered to judge themselves as looking younger if the category change was from "look my current age" at Baseline to "look younger" at Day 30 or from "look older" at Baseline to "look my current age/younger" at Day 30. | Baseline, Day 30 |
| Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire | Participants assessed their overall satisfaction at the present moment using a 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. | Day 30 |
| Protocol Violation |
|
| Other Miscellaneous Reasons |
|
| Botulinum Toxin Type A (32U) |
32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Botulinum Toxin Type A (32U) | 32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
|
|
| Secondary | Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL) | Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported. | Intent-to-treat population included all enrolled participants. | Posted | Number | percentage of participants | Day 30 |
|
|
|
| Secondary | Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : "When I look in the mirror, my facial lines make me look older than I want to look" score. | Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 2 scores ≥2 at Baseline are included in the analysis. | Posted | Number | percentage of participants | Baseline, Day 30 |
|
|
|
| Secondary | Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: "My facial lines make me look less attractive than I want to look" score. | Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 5 scores ≥2 at Baseline are included in the analysis. | Posted | Number | percentage of participants | Baseline, Day 30 |
|
|
|
| Secondary | Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: "My facial lines make me look tired" score. | Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 8 scores ≥ 3 at Baseline were included in the analysis. | Posted | Number | percentage of participants | Baseline, Day 30 |
|
|
|
| Secondary | Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | Participants were considered to judge themselves as looking younger if the category change was from "look my current age" at Baseline to "look younger" at Day 30 or from "look older" at Baseline to "look my current age/younger" at Day 30. | Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses. | Posted | Number | percentage of participants | Baseline, Day 30 |
|
|
|
| Secondary | Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire | Participants assessed their overall satisfaction at the present moment using a 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. | Intent-to-treat population included all enrolled participants. | Posted | Number | percentage of participants | Day 30 |
|
|
|
| 1 |
| 47 |
| 20 |
| 47 |
| EG001 | Botulinum Toxin Type A (32U) | 32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. | 4 | 53 | 22 | 53 |
| Appendicitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Bartholin's cyst | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment | Female population only. |
|
| Benign female reproductive tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment | Female population only. |
|
| Peritonitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 17.0 | 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 |