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
Overview
- Phase
- Not Applicable
- Intervention
- AbobotulinumtoxinA
- Conditions
- Glabellar Lines
- Sponsor
- Galderma R&D
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Detailed Description
Approximately 250 subjects are planned to be included in the study.
Investigators
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: AbobotulinumtoxinA
Outcomes
Primary Outcomes
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
- 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)