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An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intramuscular single treatment |
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| AbobotulinumtoxinA dose level 1 or 2 | Experimental | Intramuscular single treatment |
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| AbobotulinumtoxinA dose level 3 | Experimental | Intramuscular single treatment |
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| AbobotulinumtoxinA dose level 4 | Experimental | Intramuscular single treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbobotulinumtoxinA dose level 1 or 2 | Biological | Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Composite Responders at Month 1 | composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA) | 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 | Encino | California | 91436 | United States | ||
| Galderma Research Site |
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401 subjects were randomized, and 399 subjects received study product. Two (2) of the 401 randomized subjects did not receive study product due to hypertension that was identified pre-treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 AbobotulinumtoxinA | Subjects randomized (4:1) to AbobotulinumtoxinA or placebo AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines placebo: treatment of glabellar facial lines |
| FG001 | Dose Level 2 AbobotulinumtoxinA |
| 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 10, 2018 | Dec 21, 2020 |
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| placebo | Other | Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines |
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| AbobotulinumtoxinA dose 3 | Biological | Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines |
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| AbobotulinumtoxinA dose 4 | Biological | Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines |
|
| Manhattan Beach |
| California |
| 90266 |
| United States |
| Galderma Research Site | Vista | California | 92083 | United States |
| Galderma Research Site | Coral Gables | Florida | 33146 | United States |
| Galderma Research Site | Chicago | Illinois | 60611 | United States |
| Galderma Research Site | New Orleans | Louisiana | 70130 | United States |
| Galderma Research Site | New York | New York | 10028 | United States |
| Galderma Research Site | Chapel Hill | North Carolina | 27517 | United States |
| Galderma Research Site | Charlotte | North Carolina | 28207 | United States |
| Galderma Research Site | Mequon | Wisconsin | 53092 | United States |
Subjects randomized (4:1) to AbobotulinumtoxinA or placebo AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines placebo: treatment of glabellar facial lines |
| FG002 | Dose Level 3 AbobotulinumtoxinA | Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo placebo: treatment of glabellar facial lines AbobotulinumtoxinA dose 3: treatment of glabellar facial lines |
| FG003 | Dose Level 4 AbobotulinumtoxinA | Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo placebo: treatment of glabellar facial lines AbobotulinumtoxinA dose 4: treatment of glabellar facial lines |
| FG004 | Placebo | Subjects randomized to placebo |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 AbobotulinumtoxinA | Subjects randomized (4:1) to dose level 1 AbobotulinumtoxinA or placebo AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines placebo: treatment of glabellar facial lines |
| BG001 | Dose Level 2 AbobotulinumtoxinA | Subjects randomized (4:1) to dose level 2 AbobotulinumtoxinA or placebo AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines placebo: treatment of glabellar facial lines |
| BG002 | Dose Level 3 AbobotulinumtoxinA | Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo placebo: treatment of glabellar facial lines AbobotulinumtoxinA dose 3: treatment of glabellar facial lines |
| BG003 | Dose Level 4 AbobotulinumtoxinA | Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo placebo: treatment of glabellar facial lines AbobotulinumtoxinA dose 4: treatment of glabellar facial lines |
| BG004 | Placebo | Subjects randomized to placebo |
| BG005 | 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 |
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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 | Number of Composite Responders at Month 1 | composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA) | Posted | Count of Participants | Participants | Month 1 after treatment |
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36 Weeks
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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 | Dose Level 1 AbobotulinumtoxinA | Subjects randomized (4:1) to AbobotulinumtoxinA or placebo AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines placebo: treatment of glabellar facial lines | 0 | 80 | 1 | 80 | 3 | 80 |
| EG001 | Dose Level 2 AbobotulinumtoxinA | Subjects randomized (4:1) to AbobotulinumtoxinA or placebo AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines placebo: treatment of glabellar facial lines | 0 | 80 | 3 | 80 | 1 | 80 |
| EG002 | Dose Level 3 AbobotulinumtoxinA | Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo placebo: treatment of glabellar facial lines AbobotulinumtoxinA dose 3: treatment of glabellar facial lines | 0 | 80 | 0 | 80 | 1 | 80 |
| EG003 | Dose Level 4 AbobotulinumtoxinA | Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo placebo: treatment of glabellar facial lines AbobotulinumtoxinA dose 4: treatment of glabellar facial lines | 0 | 81 | 1 | 81 | 4 | 81 |
| EG004 | Placebo | Subjects randomized to placebo | 0 | 78 | 0 | 78 | 2 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Pelvic abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Hemiplegic migraine | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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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 | Apr 24, 2019 | Dec 21, 2020 | SAP_001.pdf |
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| Male |
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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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