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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| onabotulinumtoxinA 44U | Experimental | 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 two treatments 4 months apart. |
|
| onabotulinumtoxinA 24U | Other | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
|
| placebo (normal saline) | Placebo Comparator | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 will receive two treatments 4 months apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile | The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. 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 and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline. | Baseline, Day 30 |
| 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. |
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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 | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25485803 | Background | Moers-Carpi M, Carruthers J, Fagien S, Lupo M, Delmar H, Jones D, Somogyi C, Lee E, Lei X, MacKinnon S, Davis PG, Yalamanchili R, Campo A, Beddingfield FC 3rd. Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2015 Jan;41(1):102-12. doi: 10.1097/DSS.0000000000000220. |
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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 two treatments 4 months apart. |
| 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 will receive two treatments 4 months apart |
|
|
| normal saline | Drug | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart. |
|
| Day 30 |
| Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile | 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 ≥ 1-grade improvement from Baseline at Day 30 is reported. | Baseline, Day 30 |
| Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest | The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported. | Baseline, Day 30 |
| Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score | Patients rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale: 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. Lower scores indicate improvement. | Day 30 |
| Percentage of Participants Who Judged 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 With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: "When I look in the mirror, my facial lines make me look older than I want to look." 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). | 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 percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: "My facial lines make me look less attractive than I want to look." 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). | 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 percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from Baseline for FLO-11 Question #8: "My facial lines make me look tired." 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). | Baseline, Day 30 |
| Vancouver |
| British Columbia |
| Canada |
| Antibes | France |
| Berlin | Germany |
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| FG002 | Placebo (Normal Saline) | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
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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 two treatments 4 months apart. |
| BG001 | onabotulinumtoxinA 24U | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| BG002 | Placebo (Normal Saline) | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
| ||||||||||||||||
| CFL Severity as Assessed by the Investigator | Crow's Feet Line (CFL) severity as assessed at Baseline by the Investigator using the 4-point Facial Wrinkle Scale (FWS) at maximum smile. | Number | Participants |
|
| 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 Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile | The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. 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 and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline. | Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders. | Posted | Number | Percentage of participants | Baseline, Day 30 |
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| Secondary | 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. | Intent-to-treat population included all randomized participants. | Posted | Number | Percentage of participants | Day 30 |
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| Secondary | Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile | 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 ≥ 1-grade improvement from Baseline at Day 30 is reported. | Intent-to-treat population included all randomized participants. | Posted | Number | Percentage of participants | Baseline, Day 30 |
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| Secondary | Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest | The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported. | Intent-to-treat population included all randomized participants. Only those participants who were rated at least mild at Baseline are included in the analyses. | Posted | Number | Percentage of participants | Baseline, Day 30 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score | Patients rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale: 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. Lower scores indicate improvement. | Intent-to-treat population included all randomized participants. | Posted | Mean | Standard Deviation | Score on a scale | Day 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Judged 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 randomized participants. Only those participants who rated themselves as "look my current age" or "look older" at Baseline are included in the analyses. | 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 2 at Day 30 | The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: "When I look in the mirror, my facial lines make me look older than I want to look." 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). | Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included. | Posted | Number | Percentage of participants | Baseline, Day 30 |
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| Secondary | Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: "My facial lines make me look less attractive than I want to look." 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). | Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included. | Posted | Number | Percentage of participants | Baseline, Day 30 |
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| Secondary | Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from Baseline for FLO-11 Question #8: "My facial lines make me look tired." 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). | Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 3 are included. | Posted | Number | Percentage of participants | Baseline, Day 30 |
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The safety population (all randomized and treated participants) 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 two treatments 4 months apart. | 5 | 305 | 58 | 305 | ||
| EG001 | onabotulinumtoxinA 24U | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. | 8 | 306 | 51 | 306 | ||
| EG002 | Placebo (Normal Saline) | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. | 6 | 306 | 38 | 306 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Breast cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Uterine prolapse | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Rectocele | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA 14.0 | 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 |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 45 to 65 Years |
|
| >65 Years |
|
| Male |
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| Severe |
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| Units | Counts |
|---|---|
| Participants |
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Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
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Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
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Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
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