Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
Completed · Phase 4
Conditions studied: Glabellar Lines, Wrinkles
In brief
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.
Key facts
- Study ID
- NCT02718118
- Run by
- Galderma R&D
- People needed
- 60
- Starts
- 2016-04-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2022-08-01
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
Where it is running
- AboutSkin Dermatology and DermSurgery — Greenwood Village, Colorado, United States
- Skin Research Institute — Coral Gables, Florida, United States
- Marina Peredo, MD, PC — Smithtown, New York, United States
Full record on ClinicalTrials.gov
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