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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001815-38 | EudraCT Number |
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This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA Dose A | Experimental | OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
|
| OnabotulinumtoxinA Dose B | Experimental | OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
|
| Placebo followed by OnabotulinumtoxinA Dose A | Placebo Comparator | Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Biological | OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation | The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported. | Baseline, Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation | The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of "none" and "mild" are reported. | 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 |
|---|---|---|---|---|---|---|
| The Petrus Center for Aesthetic | Little Rock | Arkansas | 72205 | United States | ||
| Westside Aesthetics |
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Subjects were randomized to placebo, onabotulinumtoxinA Dose A, or onabotulinumtoxinA Dose B in Period 1. Subjects randomized to receive placebo or Dose B in Period 1, who subsequently continued to Period 2, received onabotulinumtoxinA Dose A in Period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A | Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Normal Saline | Drug | Placebo (normal saline) injected into the protocol-specified areas on Day 1. |
|
| Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest | The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported. | Baseline, Day 30 |
| Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5 | The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks "How satisfied are you with the effect your treatment had on your facial lines?" Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported. | Day 60 |
| Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points | The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis. | Baseline, Day 30 |
| Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire© | The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is "I look older than my actual age because of my facial lines" with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis. | Baseline, Day 30 |
| Time to Retreatment Eligibility | Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis. | 12 Months |
| Los Angeles |
| California |
| 90025 |
| United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Steve Yoelin, MD Medical Associates, Inc. | Newport Beach | California | 92663 | United States |
| Baumann Cosmetic & Research Institute | Miami | Florida | 33137 | United States |
| Saint Louis University | St Louis | Missouri | 63122 | United States |
| The Center For Dermatology Cosmetic and Laser Surgery | Mount Kisco | New York | 10549 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Aalst Dermatology Clinic | Aalst | Belgium |
| UZ Brussel | Jette | Belgium |
| Medical Skin Care - Sint-Truiden | Limbourg | Belgium |
| Rosenpark Research | Darmstadt | Germany |
| Hautzentrum Koeln (Cologne Dermatology) | Köln Nordrhein-Westfalen | Germany |
| Hautok und hautok-cosmetics | München | Germany |
| Praxisgemeinschaft Theatiner46 | München | Germany |
| Hautzentrum am Starnberger See GmbH | Starnberg | Germany |
| CentroDerm Study Center | Wuppertal | Germany |
| Shakespeare House Health Centre, General Practice | Basingstoke | RG24 9DT | United Kingdom |
| Medizen Clinic | Birmingham | B74 2UG | United Kingdom |
| The Bosham Clinic | Chichester | PO18 8AN | United Kingdom |
| Waverlery Medical Practice | Coatbridge | ML5 3PA | United Kingdom |
| The Gatehouse | Whitegate | CW9 8UW | United Kingdom |
| OnabotulinumtoxinA Dose B |
OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| FG002 | OnabotulinumtoxinA Dose A | OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A | Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. |
| BG001 | OnabotulinumtoxinA Dose B | OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| BG002 | OnabotulinumtoxinA Dose A | OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
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| 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 Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation | The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported. | Intent-to-Treat: all randomized subjects | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Baseline, Day 30 |
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| Secondary | Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation | The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of "none" and "mild" are reported. | Intent-to-Treat: all randomized subjects with a score of "none" and "mild" on the FWS at maximum eyebrow elevation | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Day 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest | The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported. | Intent-to-Treat: all randomized subjects with at least a 1-grade improvement assessed by the Investigator on the FWS at rest | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Baseline, Day 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5 | The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks "How satisfied are you with the effect your treatment had on your facial lines?" Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported. | Intent-to-Treat: all randomized subjects with data reported at this time point | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Day 60 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points | The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis. | Intent-to-Treat: all randomized subjects with baseline scores ≥ 20 on the Impact Domain of the FLSQ | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Baseline, Day 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire© | The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is "I look older than my actual age because of my facial lines" with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis. | Intent-to-Treat: all randomized subjects with baseline scores ≥ 3 on Item 4 of the FLO-11 | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Baseline, Day 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Retreatment Eligibility | Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis. | Intent-to-Treat: all randomized subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation | Posted | Median | Standard Deviation | Days | 12 Months |
|
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The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs. Subjects randomized to receive placebo in Period 1 who subsequently received open-label onabotulinumtoxinA Dose A in Period 2 are included in the onabotulinumtoxinA Dose A group for the Safety analysis.
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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 | Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A | Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. | 2 | 156 | 21 | 156 | ||
| EG001 | OnabotulinumtoxinA Dose B | OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. | 7 | 318 | 90 | 318 | ||
| EG002 | OnabotulinumtoxinA Dose A | OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. | 16 | 746 | 198 | 746 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
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| Ligament rupture | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Non-systematic Assessment |
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| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
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| Large intestine benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Malignant melanoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Temporal lobe epilepsy | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 19.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
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| Tonsillectomy | Surgical and medical procedures | MedDRA version 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA version 19.0 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA version 19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 19.0 | Non-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 | |
|---|---|---|---|---|
| Tanya Brandstetter | Allergan, Inc | 714-246-2567 | brandstetter_tanya@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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| >=65 years |
|
| Male |
|
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OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
|
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OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
|
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OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
|
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