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

NCT ID: NCT05089357

Last Updated: 2025-07-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-11

Study Completion Date

2023-12-24

Brief Summary

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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

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

Conditions

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Glabellar Lines

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

AbobotulinumtoxinA

Intervention Type 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.

Interventions

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AbobotulinumtoxinA

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weiming Song

Role: PRINCIPAL_INVESTIGATOR

Hangzhou Yanshuyuerong medical cosmetology clinic

Locations

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Hangzhou Yanshuyuerong medical cosmetology clinic

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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05PF2009

Identifier Type: -

Identifier Source: org_study_id

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