Trial Outcomes & Findings for Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin (NCT NCT05089357)

Last Updated: 2025-07-09

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

250 participants

Primary outcome timeframe

Month 14

Results posted on

2025-07-09

Participant Flow

This study was conducted in China from 11 November 2021 to 24 December 2023.

A total of 250 participants were enrolled and received study treatment.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	250
Overall Study Per Protocol Set (PPS)	204
Overall Study COMPLETED	216
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	23
Overall Study Lost to Follow-up	6
Overall Study Medical reason	1
Overall Study Due to completion of project, participants did not enter the follow-up window period and withdrew	2
Overall Study Pregnancy	2

Baseline Characteristics

Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AbobotulinumtoxinA n=250 Participants 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.
Age, Continuous	37.1 years STANDARD_DEVIATION 9.32 • n=5 Participants
Sex: Female, Male Female	214 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	250 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Han (East Asian)	229 Participants n=5 Participants
Race/Ethnicity, Customized Other	21 Participants n=5 Participants
Region of Enrollment China	250 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 14

Outcome measures

Outcome measures
Measure	AbobotulinumtoxinA n=204 Participants 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.
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 Interval 64.3 to 77.2
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 Interval 22.8 to 35.7
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 95 percent (%) confidence interval could not be calculated due to an insufficient number of participants with events.
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 95 percent (%) confidence interval could not be calculated due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AbobotulinumtoxinA n=204 Participants 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.
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
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	AbobotulinumtoxinA n=200 Participants 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.
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
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
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
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
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
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
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
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

Adverse Events

AbobotulinumtoxinA

Serious events: 1 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AbobotulinumtoxinA n=250 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Severe leiomyoma	0.40% 1/250 • 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.

Other adverse events

Other adverse events
Measure	AbobotulinumtoxinA n=250 participants at risk 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.
Infections and infestations COVID-19	23.2% 58/250 • 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.
Infections and infestations Upper respiratory tract infection	19.6% 49/250 • 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.

Additional Information

Clinical Scientist

Q-Med AB

Phone: +46184749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place