NCT02718118

Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.

Conditions

• Glabellar Lines
• Wrinkles

Interventions

Type	Name	Description
DEVICE	Dysport reconstituted at 1.5 mL (0.05 mL/injection)	Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
DEVICE	Dysport reconstituted at 2.5 mL (0.08 mL/injection)	Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-03-24
• Last updated: 2022-08-01
• Results posted: 2018-09-25

Locations

3 sites across 1 country: United States