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
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View full resultsBasic Information
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COMPLETED
250 participants
OBSERVATIONAL
2021-11-11
2023-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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05PF2009
Identifier Type: -
Identifier Source: org_study_id
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