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Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the treatment of platysmal bands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AbobotulinumtoxinA dose 1 | Active Comparator | AbobotulinumtoxinA dose 1 injected into platysma bands |
|
| placebo | Placebo Comparator | placebo injected into platysma bands |
|
| AbobotulinumtoxinA dose 2 | Active Comparator | AbobotulinumtoxinA dose 2 injected into platysma bands |
|
| AbobotulinumtoxinA dose 3 | Active Comparator | AbobotulinumtoxinA dose 3 injected into platysma bands |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbobotulinumtoxinA dose 1 | Biological | Treatment of platysmal bands |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo | A responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA). | Month 1 after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Encinitas | California | 92024 | United States | ||
| Galderma Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo injected into platysma bands Placebo: Treatment of platysmal bands |
| FG001 | AbobotulinumtoxinA Dose 1 | AbobotulinumtoxinA dose 1 injected into platysma bands AbobotulinumtoxinA dose 1: Treatment of platysmal bands |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2019 | Dec 21, 2020 |
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| Placebo |
| Other |
Treatment of platysmal bands |
|
| AbobotulinumtoxinA dose 2 | Biological | Treatment of platysmal bands |
|
| AbobotulinumtoxinA dose 3 | Biological | Treatment of platysmal bands |
|
| Encino |
| California |
| 91436 |
| United States |
| Galderma Research Site | Boynton Beach | Florida | 33472 | United States |
| Galderma Research Site | Miami | Florida | 33137 | United States |
| Galderma Research Site | New Orleans | Louisiana | 70115 | United States |
| Galderma Research Site | New Orleans | Louisiana | 70130 | United States |
| Galderma Research Site | Baltimore | Maryland | 21208 | United States |
| Galderma Research Site | New York | New York | 10028 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Due to business decision study did not proceed to enroll dose 2 or dose 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo injected into platysma bands Placebo: Treatment of platysmal bands |
| BG001 | AbobotulinumtoxinA Dose 1 | AbobotulinumtoxinA dose 1 injected into platysma bands AbobotulinumtoxinA dose 1: Treatment of platysmal bands |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Fitzpatrick Skin Type (FST) | FST I: white; very fair; red or blond hair; blue eyes; freckles. always burns, never tans. FST II: white; fair; red or blond hair; blue, hazel or green eyes. usually burns, tans with difficulty. FST III: cream white; fair with any eye or hair color; very common. sometimes mild burn, gradually tans. FST IV: brown; typical Mediterranean Caucasian skin. rarely burns, tans with ease. FST V: dark brown; Middle Eastern skin types. very rarely burns, tans very easily. FST VI: Skin color - black. Skin Characteristics - never burns, tans very easily. | Count of Participants | 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 | Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo | A responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA). | Due to business decision study did not proceed to enroll dose 2 or dose 3. | Posted | Count of Participants | Participants | Month 1 after treatment |
|
|
|
5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
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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 | placebo injected into platysma bands Placebo: Treatment of platysmal bands | 0 | 20 | 0 | 20 | 7 | 20 |
| EG001 | AbobotulinumtoxinA Dose 1 | AbobotulinumtoxinA dose 1 injected into platysma bands AbobotulinumtoxinA dose 1: Treatment of platysmal bands | 0 | 60 | 0 | 60 | 14 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site heamorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infectinon | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | QMedAB | (817) 961-5000 | aestheticclinicaltrials@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 23, 2019 | Dec 21, 2020 | SAP_001.pdf |
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| FST II |
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| FST III |
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| FST IV |
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| FST V |
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| FST VI |
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