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

Galderma R&D250 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Glabellar Lines

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hangzhou Yanshuyuerong medical cosmetology clinic

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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.

Time frame: Month 14

Secondary Outcomes

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.

Time frame: 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.

Time frame: Month 20

Data from ClinicalTrials.gov

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