At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Multi-Center, Subject- and Evaluator-Blinded, Parallel Comparison of Dysport®, When Reconstituted at 1.5 mL and 2.5 mL, for the Treatment of Moderate to Severe Glabellar Lines.
In Brief
A Phase 4 clinical trial evaluating Dysport reconstituted at 1.5 mL (0.05 mL/injection) and Dysport reconstituted at 2.5 mL (0.08 mL/injection) for Glabellar Lines and Wrinkles. Completed, enrolled 60 participants across 3 sites.
Detailed Summary
This study is designed to evaluate the safety, efficacy, and subject and investigator satisfaction of 2 different injection volumes of Dysport in the glabellar lines. 1. To determine the proportion of composite responders (based on blinded evaluator and subject assessments) who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) at maximum frown line on Day 30. 2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits. 3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator). 4. To assess the subject's satisfaction with the treatment. 5. To evaluate investigator satisfaction of treatment outcome. 6. To evaluate subject psychological well-being. 7. To evaluate subject age appraisal. 8. To evaluate all adverse events during the course of the study.
Study Details
Timeline
Interventions
Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.