Glabellar LinesNCT05089357

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

An observational study of Glabellar Lines, run by Galderma R&D at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Glabellar Lines
What is being tested?: AbobotulinumtoxinA
Type of treatment: Injection or infusion
How many people: 250 participants
Where: 1 siteChina
Study dates: 11 Nov 2021to 24 Dec 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Male and female adult subjects up to 65 years of age with moderate to severe glabellar lines (GL)

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Hangzhou Yanshuyuerong medical cosmetology clinic
Hangzhou, Zhejiang

Other trials in China

About this study

Official title: A Prospective, Non-interventional Study to Collect Subject and Physician Satisfaction During Long Term Treatment of Glabellar Lines With Dysport® in Subjects of Chinese Origin in Real Clinical Practice

Read the detailed description

Approximately 250 subjects are planned to be included in the study.

Conditions: Glabellar Lines
Being tested: AbobotulinumtoxinA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbobotulinumtoxinABiological
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.

Study groups in NCT05089357
Study group	Role	What they receive
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. Receives: Biological: AbobotulinumtoxinA

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Month 14

Secondary outcomes (2)

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.
Measured: 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.
Measured: Month 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202124 Dec 2023

First posted22 Oct 2021
Study start11 Nov 2021
Primary completion12 Sep 2023
Study completion24 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Glabellar LinesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05089357
Sponsor's protocol ID: 05PF2009
Status last verified: Feb 2023
First submitted: 27 Sep 2021
Last updated: 9 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines

All Glabellar Lines trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Non-interventional Study to Collect Subject and Physician Satisfaction During Long Term Treatment of Glabellar Lines With Dysport® in Subjects of Chinese Origin in Real Clinical Practice
ClinicalTrials.gov ID: NCT05089357
Acronym / sponsor ID: 05PF2009
Conditions: Glabellar Lines
Study type: Observational
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 11 Nov 2021 (actual)
Primary completion: 12 Sep 2023 (actual)
Study completion: 24 Dec 2023 (actual)
First posted: 22 Oct 2021 (actual)
Results: Posted 12 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 250 subjects are planned to be included in the study.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
AbobotulinumtoxinA	–	Biological: AbobotulinumtoxinAParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Male and female adult subjects up to 65 years of age with moderate to severe glabellar lines (GL)

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AbobotulinumtoxinAParticipants 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.	Biological	AbobotulinumtoxinA

Primary outcome

Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire
Time frame: 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.

2 secondary outcomes

Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire
Time frame: Month 14
Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire
Time frame: Month 20

Results and safety

Results posted to the registry on 12 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AbobotulinumtoxinA	250	216

Primary outcome: Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire

Time frame: Month 14. Number (95% Confidence Interval). Unit: percentage of participants

Measure	AbobotulinumtoxinA n = 204
Very Satisfied	71.1 (64.3 to 77.2)
Satisfied	28.9 (22.8 to 35.7)
Dissatisfied	0 (NA to NA)
Very Dissatisfied	0 (NA to NA)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study up to end of study (Up to 20 Months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AbobotulinumtoxinA	1 of 250 (0.4%)	107 of 250 (42.8%)	0 of 250

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Glabellar Lines

RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Weiming Song principal investigator

Hangzhou Yanshuyuerong medical cosmetology clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glabellar Lines, run by Galderma R&D at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire (time frame: Month 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05089357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.