N/A
N=250
Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin
Glabellar Lines
Bottom Line
View on ClinicalTrials.gov: NCT05089357 ↗Enrolled (actual)
250
Serious AEs
0.4%
Results posted
Feb 2025
Primary outcome: Primary: Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire — 71.1; 28.9; 0; 0 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AbobotulinumtoxinA (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire |
71.1; 28.9; 0; 0 | — |
| SECONDARY Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire |
68.1; 31.4; 0.5; 0 | — |
| SECONDARY Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire |
53.0; 44.5; 2.0; 0.5; 52.5; 45.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05089357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.