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

NCT05089357 | Completed Results

• 1 other identifier: 05PF2009
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire

  Month 14

• Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire

  Month 20

Study Arms (1)

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.

Biological: AbobotulinumtoxinA

Interventions

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.

AbobotulinumtoxinA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Hangzhou Yanshuyuerong medical cosmetology clinic

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

abobotulinumtoxinA

Results Point of Contact

• Title: Clinical Scientist
• Organization: Q-Med AB

reception.seupp@galderma.com

+46184749000

Study Officials

• Weiming Song

  Hangzhou Yanshuyuerong medical cosmetology clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 22, 2021
• Study Start: November 11, 2021
• Primary Completion: September 12, 2023
• Study Completion: December 24, 2023
• Last Updated: July 9, 2025
• Results First Posted: February 12, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)