Glabellar Lines
Conditions
Brief summary
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.
Detailed description
Approximately 250 subjects are planned to be included in the study.
Interventions
BIOLOGICALAbobotulinumtoxinA
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.
Sponsors
Galderma R&D
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult male or female up to 65 years of age, and of Chinese origin. * Moderate (grade 2) or severe (grade 3) glabellar lines at max frown. * Prior to and independent of study, subject is seeking long term treatment of their glabellar lines. * Prior to and independent of the study participation, physician intended to treat the subject with Dysport. * Time and ability to complete the study and comply with instructions. * Understands the study requirements and signed the informed consent form (ICF)
Exclusion criteria
* Hypersensitive to Dysport or its excipients. * Presence of contraindications to Dysport treatment as specified in the approved leaflet in China. * Subject is at risk for precautions, warnings, and/or contraindications to Dysport as specified in the approved leaflet in China.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire | Month 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire | Month 14 | 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. |
| Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | Month 20 | 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. |
Countries
China
Participant flow
Recruitment details
This study was conducted in China from 11 November 2021 to 24 December 2023.
Pre-assignment details
A total of 250 participants were enrolled and received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 250 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Due to completion of project, participants did not enter the follow-up window period and withdrew | 2 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Medical reason | 1 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Withdrawal by Subject | 23 |
Baseline characteristics
| Characteristic | AbobotulinumtoxinA |
|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 9.32 |
| Race/Ethnicity, Customized Han (East Asian) | 229 Participants |
| Race/Ethnicity, Customized Other | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 250 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 250 Participants |
| Sex: Female, Male Female | 214 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 250 |
| other Total, other adverse events | 107 / 250 |
| serious Total, serious adverse events | 1 / 250 |
Outcome results
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.
Time frame: Month 14
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AbobotulinumtoxinA | Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire | Very Satisfied | 71.1 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire | Satisfied | 28.9 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire | Dissatisfied | 0 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire | Very Dissatisfied | 0 percentage of participants |
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.
Time frame: Month 14
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AbobotulinumtoxinA | Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire | Very Satisfied | 68.1 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire | Satisfied | 31.4 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire | Dissatisfied | 0.5 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire | Very Dissatisfied | 0 percentage of participants |
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.
Time frame: Month 20
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AbobotulinumtoxinA | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | How satisfied are you with aesthetic outcome in injected area after treatment: Very satisfied | 53.0 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | How satisfied are you with aesthetic outcome in injected area after treatment:Satisfied | 44.5 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | How satisfied are you with aesthetic outcome in injected area after treatment:Dissatisfied | 2.0 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | How satisfied are with aesthetic outcome in injected area after treatment:Very dissatisfied | 0.5 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | How satisfied were you with comfort of injection: Very satisfied | 52.5 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | How satisfied were you with comfort of injection: Satisfied | 45.5 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | How satisfied were you with comfort of injection: Dissatisfied | 2.0 percentage of participants |
| AbobotulinumtoxinA | Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire | How satisfied were you with comfort of injection: Very Dissatisfied | 0 percentage of participants |