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An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.
Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AbobotulinumtoxinA | Other | Open-label |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbobotulinumtoxinA | Biological | AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines | Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction With Aesthetic Outcome in Treated Area | based on Subject Satisfaction questionnaire data | Months 1,3,6,7,9 and 12 |
| Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Study Site | Los Angeles | California | 90025 | United States | ||
| Galderma Study Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | abobotulinumtoxinA | open-label AbobotulinumtoxinA: AbobotulinumtoxinA treatment in the glabellar region |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AbobotulinumtoxinA | Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region |
| 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, Categorical | Count of 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 | Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines | Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit. | Modified Intent to Treat Population (all subjects treated with study product both at Baseline and Month 6) attending Month 12 visit. | Posted | Count of Participants | Participants | 12 months |
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12 months
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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 | AbobotulinumtoxinA | Open-label AbobotulinumtoxinA: AbobotulinumtoxinA treatment in the glabellar region |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominoplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment | hospitalization following abdominoplasty surgery Unrelated to study product or injection procedure Moderate in intensity |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Q-Med AB | (817) 961-5000 | aestheticclinicaltrials@galderma.com |
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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 3, 2018 | Feb 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2019 | Feb 4, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
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FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
| Months 1,3,6,7,9 and 12 |
| Evaluate the Impact of Treatment; Psychological Function | FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome. | Months 1,3,6,7,9 and 12 |
| Subject Self-Assessment Using a 4-point Categorical Scale | Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown | Months 1,3,6,7,9 and 12 |
| Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown. | Months 1,3,6,7,9 and 12 |
| Onset of Treatment Response | Subject perception of treatment response | After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit |
| San Francisco |
| California |
| 94115 |
| United States |
| Galderma Study Site | Santa Monica | California | 90404 | United States |
| Galderma Study Site | Greenwood Village | Colorado | 80111 | United States |
| Galderma Study Site | Chicago | Illinois | 60654 | United States |
| Galderma Study Site | Omaha | Nebraska | 68144 | United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Count of Participants | Participants |
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| Toxin Naive Status | Count of Participants | Participants |
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| Secondary | Subject Satisfaction With Aesthetic Outcome in Treated Area | based on Subject Satisfaction questionnaire data | Intent to Treat population (all subjects treated with study product). Number analyzed = Number of subjects completing Subject Satisfaction questionnaire at each visit following treatment. | Posted | Count of Participants | Participants | Months 1,3,6,7,9 and 12 |
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| Secondary | Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows | FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome. | Intent to Treat Population (all subjects treated with study product) attending visit. | Posted | Mean | Standard Deviation | score on a scale | Months 1,3,6,7,9 and 12 |
|
|
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| Secondary | Evaluate the Impact of Treatment; Psychological Function | FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome. | Intent to Treat Population (all subjects treated with study product) attending visit. | Posted | Mean | Standard Deviation | score on a scale | Months 1,3,6,7,9 and 12 |
|
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| Secondary | Subject Self-Assessment Using a 4-point Categorical Scale | Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown | Intent to Treat Population (all subjects treated with study product) attending visit. | Posted | Count of Participants | Participants | Months 1,3,6,7,9 and 12 |
|
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| Secondary | Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity | Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown. | Intent to Treat Population (all subjects treated with study product) attending visit. | Posted | Count of Participants | Participants | Months 1,3,6,7,9 and 12 |
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| Secondary | Onset of Treatment Response | Subject perception of treatment response | Intent to Treat Population (all subjects treated with study product) who returned diary cards. | Posted | Mean | Standard Error | days | After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit |
|
|
|
| 0 |
| 120 |
| 2 |
| 120 |
| 0 |
| 120 |
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| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment | Hospitalization for bleeding following abdominoplasty surgery Unrelated to study product or injection procedure Severe in intensity |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment | Unrelated to study product or injection procedure Moderate in intensity |
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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.
| Dissatisfied |
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| Very dissatisfied |
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| Month 3 |
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| Month 12 |
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| Mild |
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| None |
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| None |
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