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Completed

NCT Number: NCT05089357

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangzhou Yanshuyuerong medical cosmetology clinic

Hangzhou, Zhejiang, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2021
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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