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An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | AbobotulinumtoxinA |
|
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbobotulinumtoxinA | Biological | Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo | Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades 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 Study Site | Redondo Beach | California | 90277 | United States | ||
| Galderma Study Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | AbobotulinumtoxinA AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA |
| FG001 | Placebo | Placebo: Treatment of glabellar facial lines with placebo |
| 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 | Jan 24, 2019 | Apr 6, 2021 |
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| Placebo | Other | Treatment of glabellar facial lines with placebo |
|
| San Diego |
| California |
| 92121 |
| United States |
| Galderma Study Site | Westport | Connecticut | 06877 | United States |
| Galderma Study Site | Washington D.C. | District of Columbia | 20037 | United States |
| Galderma Study Site | Coral Gables | Florida | 33134 | United States |
| Galderma Study Site | Atlanta | Georgia | 30342 | United States |
| Galderma Study Site | St Louis | Missouri | 63103 | United States |
| Galderma Study Site | Omaha | Nebraska | 68144 | United States |
| Galderma Study Site | Cincinnati | Ohio | 45236 | United States |
| Galderma Study Site | Austin | Texas | 78746 | United States |
| Galderma Study Site | Spring | Texas | 77388 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | AbobotulinumtoxinA AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA |
| BG001 | Placebo | Placebo: Treatment of glabellar facial lines with placebo |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Fitzpatrick Skin Type (FST) | Fitzpatrick Skin Type (FST) is a 6 category classification schema for skin color that is a recognized tool for dermatological research that includes human skin pigmentation as a demographic variable. FST I: always burns, never tans FST II: usually burns, tans minimally FST III: sometimes mild burn, tans uniformly FST IV: burns minimally, always tans well FST V: very rarely burns, tans very easily FST VI: never burns | 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 | Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo | Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades 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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24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
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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 | Experimental | AbobotulinumtoxinA AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA | 0 | 223 | 4 | 223 | 24 | 223 |
| EG001 | Placebo | Placebo: Treatment of glabellar facial lines with placebo | 0 | 77 | 0 | 77 | 6 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening knee pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute diverticulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Long QT syndrome | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Worsening of hemorrhoids | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| injection site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | 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 | 8179615000 | aestheticclinicaltrials@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2019 | Apr 6, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
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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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