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This is a prospective, longitudinal, non-interventional, multi-center study to collect subject and physician satisfaction, and treatment experience with Dysport in real clinical practice in subjects of Chinese origin.
Approximately 250 subjects are planned to be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AbobotulinumtoxinA | Participants with moderate to severe GL received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U [0.05 mL per injection site] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbobotulinumtoxinA | Biological | Participants received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U [0.05 mL per injection site] of study drug into 5 injection sites intramuscularly. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire | The participant's satisfaction with the treatment was assessed using a subject satisfaction questionnaire. At Visit 6 (that is., three weeks, after the 3rd injection) participants were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Participant's response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here. | Month 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire | The physician's satisfaction with the treatment was assessed using a physician satisfaction questionnaire. At Visit 6 (i.e., three weeks, after the 3rd injection) Physician were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Physician response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category for overall physician satisfaction were reported here. Physicians were not considered enrolled but did contribute to this assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female adult subjects up to 65 years of age with moderate to severe glabellar lines (GL)
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| Name | Affiliation | Role |
|---|---|---|
| Weiming Song | Hangzhou Yanshuyuerong medical cosmetology clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou Yanshuyuerong medical cosmetology clinic | Hangzhou | Zhejiang | China |
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A total of 250 participants were enrolled and received study treatment.
This study was conducted in China from 11 November 2021 to 24 December 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | AbobotulinumtoxinA | Participants with moderate to severe Glabellar lines (GL) received a total dose of AbobotulinumtoxinA (Dysport®), 50 Units (U) (0.25 milliliter [mL] total; 10 U [0.05 mL per injection site] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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FAS included all participants who were screened, enrolled in the study, and treated at least once with study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | AbobotulinumtoxinA | Participants with moderate to severe GL received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U [0.05 mL per injection site] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5. |
| 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 |
| 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 Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire | The participant's satisfaction with the treatment was assessed using a subject satisfaction questionnaire. At Visit 6 (that is., three weeks, after the 3rd injection) participants were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Participant's response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here. | PPS was a subset of the FAS that included all participants who had evaluable primary efficacy endpoints, had overall good compliance, and had no major protocol deviations during the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 14 |
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From start of study up to end of study (Up to 20 Months)
The Safety Set included all participants who received at least 1 dose of study treatment and for whom actual data on safety endpoints were available.
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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 | Participants with moderate to severe Glabellar lines (GL) received AbobotulinumtoxinA (Dysport®), total dose of 50 U (0.25 milliliter [mL] total; 10 U [0.05 mL per injection site] of study drug into each of the 5 injection sites) at Visits 1, 3, and 5. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment | Event was not related to the product or injection procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment | Events were not related to the product or injection procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Q-Med AB | +46184749000 | reception.seupp@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 | Jun 28, 2021 | Jan 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2024 | Jan 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
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| Month 14 |
| Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | The participant's satisfaction with the treatment was assessed using a subject satisfaction questionnaire. Participants were asked "How satisfied with the aesthetic outcome in the Injected area after treatment" and "How satisfied were you with the comfort of the injection" Participant's response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here. | Month 20 |
| Due to completion of project, participants did not enter the follow-up window period and withdrew |
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| Pregnancy |
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| 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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Participants with moderate to severe GL received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U [0.05 mL per injection site] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5.
|
|
| Secondary | Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire | The physician's satisfaction with the treatment was assessed using a physician satisfaction questionnaire. At Visit 6 (i.e., three weeks, after the 3rd injection) Physician were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Physician response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category for overall physician satisfaction were reported here. Physicians were not considered enrolled but did contribute to this assessment. | PPS was a subset of the FAS that included all participants who had evaluable primary efficacy endpoints, had overall good compliance, and had no major protocol deviations during the study. | Posted | Number | percentage of participants | Month 14 |
|
|
|
| Secondary | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | The participant's satisfaction with the treatment was assessed using a subject satisfaction questionnaire. Participants were asked "How satisfied with the aesthetic outcome in the Injected area after treatment" and "How satisfied were you with the comfort of the injection" Participant's response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here. | PPS was a subset of the FAS that included all participants who had evaluable primary efficacy endpoints, had overall good compliance, and had no major protocol deviations during the study. Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Month 20 |
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| 0 |
| 250 |
| 1 |
| 250 |
| 107 |
| 250 |
|
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment | Events were not related to the product or injection procedure. |
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| Title | Measurements |
|---|---|
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| Very Dissatisfied |
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| How satisfied are with aesthetic outcome in injected area after treatment:Very dissatisfied |
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| How satisfied were you with comfort of injection: Very satisfied |
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| How satisfied were you with comfort of injection: Satisfied |
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| How satisfied were you with comfort of injection: Dissatisfied |
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| How satisfied were you with comfort of injection: Very Dissatisfied |
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