Glabellar Lines Clinical Trial
Official 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
| Verified date | February 2023 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | December 24, 2023 |
| Est. primary completion date | September 12, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Hangzhou Yanshuyuerong medical cosmetology clinic | Hangzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Subject satisfaction assessed by Subject Satisfaction Questionnaire | At Visit 6 (i.e., three weeks, after the 3rd injection) subjects will be asked "What is your overall satisfaction after three treatment cycles?" Response options: Very Satisfied Satisfied Dissatisfied Very Dissatisfied The primary endpoint will evaluate the proportion of subjects in each response category |
3 weeks after 3rd injection |
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